バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:30
主な臨床検査値の推移（045 試験）（続き）
3）ベースラインからの個々の変化量
Individual Change From Baseline in Neutrophils (/microL) Over Time
(All Patients as Treated)
24-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV
10000
Change From Baseline
in Neutrophils (/microL)
5000
0
-5000
-10000
012345678910
11
12
16
20
24
FU4
FU12
FU20 FU24
Weeks Since Randomization
2.7.4
臨床的安全性
-
563
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:30
主な臨床検査値の推移（045 試験）（続き）
3）ベースラインからの個々の変化量
Individual Change From Baseline in Creatinine (mg/dL) Over Time
(All Patients as Treated)
24-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV
0.2
0.1
Change From Baseline
in Creatinine (mg/dL)
0.0
-0.1
-0.2
-0.3
-0.4
-0.5
012345678
10 12
16
20
24
FU4
FU12
FU20 FU24
Weeks Since Randomization
2.7.4
臨床的安全性
-
564
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:30
主な臨床検査値の推移（045 試験）（続き）
3）ベースラインからの個々の変化量
Individual Change From Baseline in Aspartate Aminotransferase (IU/L) Over Time
(All Patients as Treated)
24-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV
300
Change From Baseline
in Aspartate Aminotransferase (IU/L)
200
100
0
-100
-200
012345678
10 12
16
20
24
FU4
FU12
FU20 FU24
Weeks Since Randomization
2.7.4
臨床的安全性
-
565
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:30
主な臨床検査値の推移（045 試験）（続き）
3）ベースラインからの個々の変化量
Individual Change From Baseline in Alanine Aminotransferase (IU/L) Over Time
(All Patients as Treated)
24-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV
500
400
Change From Baseline
in Alanine Aminotransferase (IU/L)
300
200
100
0
-100
-200
012345678
10 12
16
20
24
FU4
FU12
FU20 FU24
Weeks Since Randomization
2.7.4
臨床的安全性
-
566
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:30
主な臨床検査値の推移（045 試験）（続き）
3）ベースラインからの個々の変化量
Individual Change From Baseline in Bilirubin (mg/dL) Over Time
(All Patients as Treated)
24-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV
1.5
Change From Baseline
in Bilirubin (mg/dL)
1.0
0.5
0.0
-0.5
-1.0
012345678
10 12
16
20
24
FU4
FU12
FU20 FU24
Weeks Since Randomization
2.7.4
臨床的安全性
-
567
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31 有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）
Patients in population
with one or more adverse
events
with no adverse events
Blood and lymphatic system
disorders
Anaemia
Leukopenia
Neutropenia
Pancytopenia
Cardiac disorders
Angina pectoris
Palpitations
Tachycardia
Placebo + Peg-IFN +
Ribavirin
n
(%)
19
18
(94.7)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
18
15
(83.3)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
20
18
(90.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
18
16
(88.9)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
19
18
(94.7)
1
(5.3)
3
(16.7)
2
(10.0)
2
(11.1)
1
(5.3)
4
(21.1)
2
(11.1)
2
(10.0)
0
(0.0)
4
(21.1)
3
0
1
0
1
1
0
1
(15.8)
(0.0)
(5.3)
(0.0)
(5.3)
(5.3)
(0.0)
(5.3)
1
0
1
0
0
0
0
0
(5.6)
(0.0)
(5.6)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
1
0
2
0
1
0
1
0
(5.0)
(0.0)
(10.0)
(0.0)
(5.0)
(0.0)
(5.0)
(0.0)
0
0
0
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
1
2
1
1
0
1
0
(0.0)
(5.3)
(10.5)
(5.3)
(5.3)
(0.0)
(5.3)
(0.0)
2.7.4
臨床的安全性
-
568
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Ear and labyrinth disorders
Tinnitus
Eye disorders
Dry eye
Eye irritation
Eye pain
Eye pruritus
Eye swelling
Lacrimation increased
Ocular icterus
Photopsia
Vision blurred
Xerophthalmia
Gastrointestinal disorders
Abdominal discomfort
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
5
(26.3)
1
(5.3)
1
(5.3)
1
(5.3)
1
(5.3)
1
(5.3)
0
(0.0)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
14
(73.7)
0
(0.0)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
0
(0.0)
0
(0.0)
3
(16.7)
1
(5.6)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
1
(5.6)
11
(61.1)
1
(5.6)
2.7.4
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
1
(5.0)
1
(5.0)
3
(15.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.0)
14
(70.0)
1
(5.0)
臨床的安全性
-
569
-
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
0
(0.0)
0
(0.0)
1
(5.6)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
11
(61.1)
0
(0.0)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
0
(0.0)
0
(0.0)
2
(10.5)
1
(5.3)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
0
(0.0)
14
(73.7)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Gastrointestinal disorders
Abdominal pain
Abdominal pain upper
Anal fissure
Constipation
Diarrhoea
Dry mouth
Dyspepsia
Flatulence
Gastritis
Gastrooesophageal reflux
disease
Gingival bleeding
Glossodynia
Haemorrhoids
Lip dry
Nausea
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
14
(73.7)
0
(0.0)
3
(15.8)
0
(0.0)
1
(5.3)
4
(21.1)
0
(0.0)
4
(21.1)
0
(0.0)
0
(0.0)
1
(5.3)
0
0
0
2
5
(0.0)
(0.0)
(0.0)
(10.5)
(26.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
1
(5.6)
1
(5.6)
4
(22.2)
1
(5.6)
0
(0.0)
2
(11.1)
0
0
0
0
5
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
14
(70.0)
1
(5.0)
2
(10.0)
1
(5.0)
0
(0.0)
6
(30.0)
2
(10.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(27.8)
2.7.4
1
0
1
0
8
臨床的安全性
-
570
-
(5.0)
(0.0)
(5.0)
(0.0)
(40.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
1
(5.6)
4
(22.2)
0
(0.0)
0
(0.0)
2
(11.1)
2
(11.1)
2
(11.1)
0
(0.0)
0
(0.0)
2
(11.1)
0
1
0
0
7
(0.0)
(5.6)
(0.0)
(0.0)
(38.9)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
14
(73.7)
0
(0.0)
2
(10.5)
0
(0.0)
0
(0.0)
4
(21.1)
1
(5.3)
4
(21.1)
0
(0.0)
2
(10.5)
0
(0.0)
0
0
0
1
6
(0.0)
(0.0)
(0.0)
(5.3)
(31.6)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Gastrointestinal disorders
Oesophageal pain
Stomatitis
Vomiting
General disorders and
administration site
conditions
Asthenia
Chest pain
Chills
Discomfort
Fatigue
Feeling cold
Feeling of body
temperature chan
Influenza like illness
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
14
(73.7)
0
(0.0)
1
(5.3)
0
(0.0)
11
(57.9)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
0
(0.0)
1
(5.6)
0
(0.0)
8
(44.4)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
14
(70.0)
0
(0.0)
0
(0.0)
8
(40.0)
11
(55.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
0
(0.0)
0
(0.0)
3
(16.7)
11
(61.1)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
14
(73.7)
1
(5.3)
0
(0.0)
3
(15.8)
12
(63.2)
3
0
2
0
7
0
0
(15.8)
(0.0)
(10.5)
(0.0)
(36.8)
(0.0)
(0.0)
2
0
1
0
3
0
0
(11.1)
(0.0)
(5.6)
(0.0)
(16.7)
(0.0)
(0.0)
2
0
1
0
7
0
1
(10.0)
(0.0)
(5.0)
(0.0)
(35.0)
(0.0)
(5.0)
3
0
0
0
4
0
0
(16.7)
(0.0)
(0.0)
(0.0)
(22.2)
(0.0)
(0.0)
1
2
3
1
2
1
0
(5.3)
(10.5)
(15.8)
(5.3)
(10.5)
(5.3)
(0.0)
4
(21.1)
4
(22.2)
4
(20.0)
4
(22.2)
5
(26.3)
2.7.4
臨床的安全性
-
571
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
General disorders and
administration site
conditions
Injection site erythema
Injection site irritation
Injection site reaction
Irritability
Oedema peripheral
Pain
Pyrexia
Infections and infestations
Bronchitis
Herpes virus infection
Infected sebaceous cyst
Nasopharyngitis
Sinusitis
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
11
(57.9)
0
0
0
2
0
0
2
3
1
0
0
0
1
(0.0)
(0.0)
(0.0)
(10.5)
(0.0)
(0.0)
(10.5)
(15.8)
(5.3)
(0.0)
(0.0)
(0.0)
(5.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
8
(44.4)
1
1
1
2
0
0
0
2
0
0
0
0
0
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
11
(55.0)
(5.6)
(5.6)
(5.6)
(11.1)
(0.0)
(0.0)
(0.0)
(11.1)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
2
0
1
1
0
3
1
4
1
0
1
1
0
臨床的安全性
-
572
-
(10.0)
(0.0)
(5.0)
(5.0)
(0.0)
(15.0)
(5.0)
(20.0)
(5.0)
(0.0)
(5.0)
(5.0)
(0.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
1
0
0
0
1
0
1
6
0
0
0
0
1
(5.6)
(0.0)
(0.0)
(0.0)
(5.6)
(0.0)
(5.6)
(33.3)
(0.0)
(0.0)
(0.0)
(0.0)
(5.6)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
12
(63.2)
0
0
0
1
0
0
4
5
0
1
0
2
0
(0.0)
(0.0)
(0.0)
(5.3)
(0.0)
(0.0)
(21.1)
(26.3)
(0.0)
(5.3)
(0.0)
(10.5)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Infections and infestations
Skin infection
Tinea infection
Tracheobronchitis
Upper respiratory tract
infectio
Urinary tract infection
Viral infection
Vulvovaginal mycotic
infection
Injury, poisoning and
procedural complications
Burns second degree
Contusion
Post-traumatic pain
Thermal burn
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
3
(15.8)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
2
(11.1)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
4
(20.0)
1
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
6
(33.3)
0
(0.0)
1
(5.6)
0
(0.0)
1
(5.6)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
5
(26.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
1
0
(0.0)
(5.6)
(0.0)
1
0
0
(5.0)
(0.0)
(0.0)
2
0
1
(11.1)
(0.0)
(5.6)
1
1
0
(5.3)
(5.3)
(0.0)
0
(0.0)
0
(0.0)
2
(10.0)
0
(0.0)
1
(5.3)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
1
0
1
(5.0)
(5.0)
(0.0)
(5.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
1
0
(0.0)
(0.0)
(5.3)
(0.0)
2.7.4
臨床的安全性
-
573
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Investigations
Blood bilirubin increased
Blood glucose increased
Body temperature
decreased
Body temperature
increased
Glucose urine present
Haemoglobin decreased
Neutrophil count
decreased
Weight decreased
White blood cell count
decreased
Metabolism and nutrition
disorders
Decreased appetite
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
3
(15.8)
0
(0.0)
1
(5.3)
1
(5.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
3
(16.7)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
3
(15.0)
1
(5.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
2
(11.1)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
2
(10.5)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
1
(5.6)
0
(0.0)
1
(5.6)
1
(5.3)
1
0
0
(5.3)
(0.0)
(0.0)
0
0
1
(0.0)
(0.0)
(5.6)
0
0
1
(0.0)
(0.0)
(5.0)
0
1
0
(0.0)
(5.6)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
(5.3)
(0.0)
0
1
(0.0)
(5.6)
2
0
(10.0)
(0.0)
0
0
(0.0)
(0.0)
0
1
(0.0)
(5.3)
2
(10.5)
4
(22.2)
5
(25.0)
2
(11.1)
1
(5.3)
2
(10.5)
4
(22.2)
5
(25.0)
2
(11.1)
1
(5.3)
2.7.4
臨床的安全性
-
574
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Musculoskeletal and
connective tissue disorders
Arthralgia
Back pain
Muscular weakness
Musculoskeletal chest
pain
Musculoskeletal pain
Myalgia
Myosclerosis
Pain in extremity
Nervous system disorders
Cervicobrachial syndrome
Disturbance in attention
Dizziness
Dysgeusia
Head discomfort
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
6
(31.6)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
6
(33.3)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
4
(20.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
3
(16.7)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
3
(15.8)
1
1
1
1
(5.3)
(5.3)
(5.3)
(5.3)
3
0
0
0
(16.7)
(0.0)
(0.0)
(0.0)
2
3
0
0
(10.0)
(15.0)
(0.0)
(0.0)
1
0
0
0
(5.6)
(0.0)
(0.0)
(0.0)
0
2
0
0
(0.0)
(10.5)
(0.0)
(0.0)
0
3
0
0
7
0
0
0
0
1
(0.0)
(15.8)
(0.0)
(0.0)
(36.8)
(0.0)
(0.0)
(0.0)
(0.0)
(5.3)
2
1
0
0
6
0
1
1
0
0
(11.1)
(5.6)
(0.0)
(0.0)
(33.3)
(0.0)
(5.6)
(5.6)
(0.0)
(0.0)
0
1
0
1
10
0
0
0
0
0
(0.0)
(5.0)
(0.0)
(5.0)
(50.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2
1
0
0
11
0
0
0
1
0
(11.1)
(5.6)
(0.0)
(0.0)
(61.1)
(0.0)
(0.0)
(0.0)
(5.6)
(0.0)
0
0
1
0
7
1
0
0
1
0
(0.0)
(0.0)
(5.3)
(0.0)
(36.8)
(5.3)
(0.0)
(0.0)
(5.3)
(0.0)
2.7.4
臨床的安全性
-
575
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Nervous system disorders
Headache
Hyperaesthesia
Memory impairment
Migraine
Paraesthesia
Poor quality sleep
Restless legs syndrome
Somnolence
Psychiatric disorders
Abnormal dreams
Agitation
Anxiety
Depressed mood
Depression
Initial insomnia
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
7
(36.8)
7
(36.8)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
0
(0.0)
6
(31.6)
0
(0.0)
1
(5.3)
0
(0.0)
0
(0.0)
2
(10.5)
1
(5.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
6
(33.3)
4
(22.2)
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
5
(27.8)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
2.7.4
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
10
(50.0)
9
(45.0)
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
2
(10.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.0)
1
(5.0)
0
(0.0)
臨床的安全性
-
576
-
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
11
(61.1)
8
(44.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(11.1)
5
(27.8)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
7
(36.8)
4
(21.1)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
0
(0.0)
1
(5.3)
1
(5.3)
4
(21.1)
0
(0.0)
0
(0.0)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Psychiatric disorders
Insomnia
Libido decreased
Mood swings
Nervousness
Restlessness
Sleep disorder
Renal and urinary disorders
Pollakiuria
Urine odour abnormal
Reproductive system and
breast disorders
Erectile dysfunction
Menstrual disorder
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
6
(31.6)
2
(10.5)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
5
(27.8)
4
(22.2)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(11.1)
1
(5.6)
1
(5.6)
1
(5.6)
1
0
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
2
(10.0)
1
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.0)
(5.6)
(0.0)
2.7.4
0
1
臨床的安全性
-
577
-
(0.0)
(5.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
5
(27.8)
3
(16.7)
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
4
(21.1)
2
(10.5)
0
(0.0)
0
(0.0)
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Respiratory, thoracic and
mediastinal disorders
Cough
Dry throat
Dyspnoea
Epistaxis
Nasal congestion
Nasal dryness
Oropharyngeal pain
Productive cough
Rhinorrhoea
Sinus congestion
Throat irritation
Skin and subcutaneous
tissue disorders
Alopecia
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
4
(21.1)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
4
(22.2)
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
3
(15.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
4
(22.2)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
4
(21.1)
0
0
3
0
0
0
0
0
0
1
0
9
(0.0)
(0.0)
(15.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(5.3)
(0.0)
(47.4)
2
0
3
0
1
0
0
0
0
0
0
8
(11.1)
(0.0)
(16.7)
(0.0)
(5.6)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(44.4)
0
0
0
0
2
1
1
2
1
0
0
5
(0.0)
(0.0)
(0.0)
(0.0)
(10.0)
(5.0)
(5.0)
(10.0)
(5.0)
(0.0)
(0.0)
(25.0)
2
1
0
0
0
0
0
0
0
0
1
5
(11.1)
(5.6)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(5.6)
(27.8)
0
0
2
1
0
0
1
0
0
0
0
6
(0.0)
(0.0)
(10.5)
(5.3)
(0.0)
(0.0)
(5.3)
(0.0)
(0.0)
(0.0)
(0.0)
(31.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
2.7.4
臨床的安全性
-
578
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
Skin and subcutaneous
tissue disorders
Dermatitis
Dry skin
Eczema
Erythema
Hyperhidrosis
Night sweats
Pruritus
Rash
Rash papular
Rash vesicular
Skin burning sensation
Skin reaction
Skin ulcer
Vascular disorders
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
n
(%)
9
(47.4)
0
3
0
1
0
1
3
4
0
0
0
1
0
1
(0.0)
(15.8)
(0.0)
(5.3)
(0.0)
(5.3)
(15.8)
(21.1)
(0.0)
(0.0)
(0.0)
(5.3)
(0.0)
(5.3)
MK-7009 300 mg bid +
Peg-IFN + Ribavirin
n
(%)
8
(44.4)
0
1
1
1
0
1
3
2
1
0
0
0
0
0
MK-7009 600 mg bid +
Peg-IFN + Ribavirin
n
(%)
5
(25.0)
(0.0)
(5.6)
(5.6)
(5.6)
(0.0)
(5.6)
(16.7)
(11.1)
(5.6)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
0
0
1
0
1
0
0
2
0
1
1
0
0
0
臨床的安全性
-
579
-
(0.0)
(0.0)
(5.0)
(0.0)
(5.0)
(0.0)
(0.0)
(10.0)
(0.0)
(5.0)
(5.0)
(0.0)
(0.0)
(0.0)
MK-7009 600 mg qd +
Peg-IFN + Ribavirin
n
(%)
5
(27.8)
1
1
0
1
0
0
1
3
0
0
0
0
1
1
(5.6)
(5.6)
(0.0)
(5.6)
(0.0)
(0.0)
(5.6)
(16.7)
(0.0)
(0.0)
(0.0)
(0.0)
(5.6)
(5.6)
MK-7009 800 mg qd +
Peg-IFN + Ribavirin
n
(%)
6
(31.6)
0
1
1
0
0
0
2
2
1
0
0
0
0
1
(0.0)
(5.3)
(5.3)
(0.0)
(0.0)
(0.0)
(10.5)
(10.5)
(5.3)
(0.0)
(0.0)
(0.0)
(0.0)
(5.3)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:31
有害事象発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
MK-7009 300 mg bid + MK-7009 600 mg bid +
MK-7009 600 mg qd +
MK-7009 800 mg qd +
Ribavirin
Peg-IFN + Ribavirin
Peg-IFN + Ribavirin
Peg-IFN + Ribavirin
Peg-IFN + Ribavirin
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
Vascular disorders
1
(5.3)
0
(0.0)
0
(0.0)
1
(5.6)
1
(5.3)
Hot flush
1
(5.3)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
Hyperaemia
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
Every patient is counted a single time for each applicable specific adverse event. A patient with multiple adverse events within a system organ class is counted a
single time for that system organ class.
A system organ class or specific adverse event appears on this report only if its incidence in one or more of the columns is greater than or equal to the percent
incidence specified in the report title, after rounding.
2.7.4
臨床的安全性
-
580
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32 有害事象発現例数（009 試験：非肝硬変患者）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Patients in population
with one or more adverse
events
with no adverse events
Blood and lymphatic system
disorders
Anaemia
Anisocytosis
Leukopenia
Lymphadenitis
Lymphadenopathy
Neutropenia
Thrombocytopenia
(%)
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
42
42
(100.0)
n
40
38
(95.0)
2
(5.0)
0
10
(25.0)
5
0
2
0
0
8
1
(12.5)
(0.0)
(5.0)
(0.0)
(0.0)
(20.0)
(2.5)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
41
40
(0.0)
12
8
1
2
0
1
5
0
(97.6)
n
46
46
1
(2.4)
(28.6)
13
(19.0)
(2.4)
(4.8)
(0.0)
(2.4)
(11.9)
(0.0)
8
1
0
0
1
3
1
2.7.4
臨床的安全性
-
581
-
(%)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
(%)
48-wk PBO + Peg-IFN
+ RBV
(100.0)
n
42
41
(%)
(97.6)
0
(0.0)
1
(2.4)
(31.7)
12
(26.1)
8
(19.0)
(19.5)
(2.4)
(0.0)
(0.0)
(2.4)
(7.3)
(2.4)
5
0
1
0
0
8
1
(10.9)
(0.0)
(2.2)
(0.0)
(0.0)
(17.4)
(2.2)
7
0
0
1
0
2
1
(16.7)
(0.0)
(0.0)
(2.4)
(0.0)
(4.8)
(2.4)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32 有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Cardiac disorders
Bradycardia
Cardiac failure congestive
Palpitations
Tachycardia
Congenital, familial and
genetic disorders
Ichthyosis
Ear and labyrinth disorders
Deafness unilateral
Ear pain
Hyperacusis
n
2
1
0
1
0
0
(%)
(5.0)
(2.5)
(0.0)
(2.5)
(0.0)
(0.0)
0
4
0
1
0
(0.0)
(10.0)
(0.0)
(2.5)
(0.0)
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
2
(4.8)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
0
(0.0)
0
2
0
1
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(4.8)
(0.0)
(2.4)
(0.0)
2.7.4
582
-
48-wk PBO + Peg-IFN
+ RBV
n
0
0
0
0
0
1
(%)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
n
4
0
0
4
0
0
(%)
(8.7)
(0.0)
(0.0)
(8.7)
(0.0)
(0.0)
n
1
0
0
1
0
0
(%)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
1
3
1
1
0
(2.4)
(7.3)
(2.4)
(2.4)
(0.0)
0
5
0
3
1
(0.0)
(10.9)
(0.0)
(6.5)
(2.2)
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32 有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Ear and labyrinth disorders
Hypoacusis
Tinnitus
Vertigo
Endocrine disorders
Autoimmune thyroiditis
Hyperthyroidism
Hypothyroidism
Eye disorders
Blepharitis
Chalazion
Conjunctival
haemorrhage
n
4
0
0
3
1
0
0
1
4
0
0
0
(%)
(10.0)
(0.0)
(0.0)
(7.5)
(2.5)
(0.0)
(0.0)
(2.5)
(10.0)
(0.0)
(0.0)
(0.0)
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
2
(4.8)
0
(0.0)
0
(0.0)
2
(4.8)
2
(4.8)
1
(2.4)
0
(0.0)
1
(2.4)
3
(7.1)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
3
1
0
2
1
0
0
1
8
0
1
1
臨床的安全性
-
583
-
(%)
(7.3)
(2.4)
(0.0)
(4.9)
(2.4)
(0.0)
(0.0)
(2.4)
(19.5)
(0.0)
(2.4)
(2.4)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
5
0
1
1
4
0
2
3
10
0
0
0
(%)
(10.9)
(0.0)
(2.2)
(2.2)
(8.7)
(0.0)
(4.3)
(6.5)
(21.7)
(0.0)
(0.0)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
0
0
0
0
2
0
0
2
4
1
0
1
(%)
(0.0)
(0.0)
(0.0)
(0.0)
(4.8)
(0.0)
(0.0)
(4.8)
(9.5)
(2.4)
(0.0)
(2.4)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Eye disorders
Conjunctivitis
Diplopia
Dry eye
Eczema eyelids
Eye disorder
Eye irritation
Eye pain
Eye pruritus
Myopia
Ocular hyperaemia
Photophobia
Presbyopia
Retinal detachment
n
4
3
0
1
1
0
0
0
0
0
0
0
0
0
(%)
(10.0)
(7.5)
(0.0)
(2.5)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
8
1
0
4
0
0
1
0
0
0
0
1
0
0
臨床的安全性
-
584
-
(%)
(19.5)
(2.4)
(0.0)
(9.8)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
10
2
0
2
0
0
0
0
1
1
0
0
2
1
(%)
(21.7)
(4.3)
(0.0)
(4.3)
(0.0)
(0.0)
(0.0)
(0.0)
(2.2)
(2.2)
(0.0)
(0.0)
(4.3)
(2.2)
48-wk PBO + Peg-IFN
+ RBV
n
4
1
0
2
0
0
0
1
0
0
1
0
0
0
(%)
(9.5)
(2.4)
(0.0)
(4.8)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Eye disorders
Retinal vascular
thrombosis
Vision blurred
Visual acuity reduced
Visual impairment
Vitreous floaters
Xerophthalmia
Gastrointestinal disorders
Abdominal discomfort
Abdominal distension
Abdominal pain
Abdominal pain lower
Abdominal pain upper
n
4
0
(%)
(10.0)
(0.0)
0
2
0
0
0
32
0
1
4
1
4
(0.0)
(5.0)
(0.0)
(0.0)
(0.0)
(80.0)
(0.0)
(2.5)
(10.0)
(2.5)
(10.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
0
(0.0)
0
1
0
1
0
35
0
0
4
2
7
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(2.4)
(0.0)
(2.4)
(0.0)
(83.3)
(0.0)
(0.0)
(9.5)
(4.8)
(16.7)
2.7.4
585
-
48-wk PBO + Peg-IFN
+ RBV
n
8
0
(%)
(19.5)
(0.0)
n
10
1
(%)
(21.7)
(2.2)
n
4
0
(%)
(9.5)
(0.0)
2
0
0
0
1
32
0
2
3
1
2
(4.9)
(0.0)
(0.0)
(0.0)
(2.4)
(78.0)
(0.0)
(4.9)
(7.3)
(2.4)
(4.9)
0
2
2
0
0
41
1
2
4
0
5
(0.0)
(4.3)
(4.3)
(0.0)
(0.0)
(89.1)
(2.2)
(4.3)
(8.7)
(0.0)
(10.9)
0
0
0
0
0
23
0
1
2
2
5
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(54.8)
(0.0)
(2.4)
(4.8)
(4.8)
(11.9)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal disorders
Abdominal rigidity
Abnormal faeces
Anal fissure
Aphthous stomatitis
Chapped lips
Cheilitis
Constipation
Crohn's disease
Dental caries
Diarrhoea
Dry mouth
Dyspepsia
Dysphagia
n
32
0
0
0
2
1
0
2
0
1
17
3
13
1
(%)
(80.0)
(0.0)
(0.0)
(0.0)
(5.0)
(2.5)
(0.0)
(5.0)
(0.0)
(2.5)
(42.5)
(7.5)
(32.5)
(2.5)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
35
(83.3)
0
(0.0)
1
(2.4)
1
(2.4)
3
(7.1)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
18
(42.9)
0
(0.0)
9
(21.4)
1
(2.4)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
32
0
0
0
1
0
0
1
1
1
13
2
9
2
臨床的安全性
-
586
-
(%)
(78.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(2.4)
(2.4)
(31.7)
(4.9)
(22.0)
(4.9)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
41
1
0
0
0
0
0
3
0
1
25
2
6
0
(%)
(89.1)
(2.2)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(6.5)
(0.0)
(2.2)
(54.3)
(4.3)
(13.0)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
23
0
0
0
2
0
0
0
0
0
5
1
5
0
(%)
(54.8)
(0.0)
(0.0)
(0.0)
(4.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(11.9)
(2.4)
(11.9)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal disorders
Epigastric discomfort
Eructation
Faeces discoloured
Flatulence
Frequent bowel
movements
Gastritis
Gastritis erosive
Gastritis haemorrhagic
Gastrointestinal disorder
Gastrointestinal pain
Gastrooesophageal reflux
disease
Gingival bleeding
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
35
(83.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
n
32
0
1
1
1
1
(%)
(80.0)
(0.0)
(2.5)
(2.5)
(2.5)
(2.5)
0
0
0
2
0
7
(0.0)
(0.0)
(0.0)
(5.0)
(0.0)
(17.5)
0
0
0
0
0
3
0
(0.0)
1
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
32
1
0
0
1
0
(%)
(78.0)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
n
41
1
0
0
0
0
(%)
(89.1)
(2.2)
(0.0)
(0.0)
(0.0)
(0.0)
n
23
0
0
1
0
0
(%)
(54.8)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(7.1)
0
1
1
0
0
4
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
(9.8)
1
0
0
0
1
5
(2.2)
(0.0)
(0.0)
(0.0)
(2.2)
(10.9)
0
0
0
0
0
1
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
0
(0.0)
2
(4.3)
0
(0.0)
2.7.4
臨床的安全性
-
587
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal disorders
Gingival pain
Gingivitis
Glossitis
Glossodynia
Haemorrhoidal
haemorrhage
Haemorrhoids
Infrequent bowel
movements
Lip dry
Mouth ulceration
Nausea
Oesophageal pain
Oral disorder
Oral mucosal blistering
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
35
(83.3)
0
(0.0)
1
(2.4)
1
(2.4)
0
(0.0)
0
(0.0)
n
32
0
3
0
1
1
(%)
(80.0)
(0.0)
(7.5)
(0.0)
(2.5)
(2.5)
2
0
(5.0)
(0.0)
2
0
0
1
20
0
0
1
(0.0)
(2.5)
(50.0)
(0.0)
(0.0)
(2.5)
0
1
16
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
32
2
1
0
0
0
(%)
(78.0)
(4.9)
(2.4)
(0.0)
(0.0)
(0.0)
n
41
0
0
1
0
0
(%)
(89.1)
(0.0)
(0.0)
(2.2)
(0.0)
(0.0)
n
23
1
0
0
1
0
(%)
(54.8)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(4.8)
(0.0)
2
0
(4.9)
(0.0)
2
0
(4.3)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
(2.4)
(38.1)
(0.0)
(0.0)
(0.0)
0
1
13
2
0
0
(0.0)
(2.4)
(31.7)
(4.9)
(0.0)
(0.0)
0
3
29
0
0
0
(0.0)
(6.5)
(63.0)
(0.0)
(0.0)
(0.0)
1
3
6
1
1
1
(2.4)
(7.1)
(14.3)
(2.4)
(2.4)
(2.4)
2.7.4
臨床的安全性
-
588
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal disorders
Portal hypertensive
gastropathy
Proctalgia
Proctitis
Reflux gastritis
Retching
Stomatitis
Tongue ulceration
Tooth disorder
Toothache
Upper gastrointestinal
haemorrhage
Varices oesophageal
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
35
(83.3)
0
(0.0)
n
32
0
(%)
(80.0)
(0.0)
1
0
0
0
0
0
0
1
0
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
0
0
0
0
1
0
0
0
0
0
(0.0)
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
32
1
(%)
(78.0)
(2.4)
n
41
0
(%)
(89.1)
(0.0)
n
23
0
(%)
(54.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
1
0
1
0
0
2
0
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
(0.0)
(0.0)
(4.9)
(0.0)
0
1
0
1
0
0
1
1
1
(0.0)
(2.2)
(0.0)
(2.2)
(0.0)
(0.0)
(2.2)
(2.2)
(2.2)
0
0
0
0
0
1
0
2
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(4.8)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
589
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal disorders
Vomiting
General disorders and
administration site
conditions
Asthenia
Chest discomfort
Chest pain
Chills
Early satiety
Face oedema
Fatigue
Feeling abnormal
n
32
12
35
(%)
(80.0)
(30.0)
(87.5)
9
0
1
2
0
0
19
0
(22.5)
(0.0)
(2.5)
(5.0)
(0.0)
(0.0)
(47.5)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
35
(83.3)
12
(28.6)
31
(73.8)
11
0
2
4
0
0
16
1
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(26.2)
(0.0)
(4.8)
(9.5)
(0.0)
(0.0)
(38.1)
(2.4)
2.7.4
590
-
48-wk PBO + Peg-IFN
+ RBV
n
32
5
34
(%)
(78.0)
(12.2)
(82.9)
n
41
13
32
(%)
(89.1)
(28.3)
(69.6)
n
23
1
31
(%)
(54.8)
(2.4)
(73.8)
10
0
0
4
0
1
18
0
(24.4)
(0.0)
(0.0)
(9.8)
(0.0)
(2.4)
(43.9)
(0.0)
10
2
2
1
1
0
13
0
(21.7)
(4.3)
(4.3)
(2.2)
(2.2)
(0.0)
(28.3)
(0.0)
10
0
0
0
0
0
10
0
(23.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(23.8)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
General disorders and
administration site
conditions
Feeling hot
General physical health
deterioration
Influenza like illness
Injection site erythema
Injection site
inflammation
Injection site pain
Injection site pruritus
Injection site reaction
Irritability
Mass
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
31
(73.8)
n
35
(%)
(87.5)
0
0
(0.0)
(0.0)
0
1
10
2
0
(25.0)
(5.0)
(0.0)
1
2
0
3
0
(2.5)
(5.0)
(0.0)
(7.5)
(0.0)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
34
(%)
(82.9)
n
32
(%)
(69.6)
n
31
(%)
(73.8)
(0.0)
(2.4)
3
0
(7.3)
(0.0)
0
1
(0.0)
(2.2)
0
0
(0.0)
(0.0)
9
2
0
(21.4)
(4.8)
(0.0)
14
2
2
(34.1)
(4.9)
(4.9)
10
1
0
(21.7)
(2.2)
(0.0)
9
0
0
(21.4)
(0.0)
(0.0)
1
0
1
4
0
(2.4)
(0.0)
(2.4)
(9.5)
(0.0)
1
0
1
4
1
(2.4)
(0.0)
(2.4)
(9.8)
(2.4)
0
0
1
5
0
(0.0)
(0.0)
(2.2)
(10.9)
(0.0)
0
0
1
7
0
(0.0)
(0.0)
(2.4)
(16.7)
(0.0)
2.7.4
臨床的安全性
-
591
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
General disorders and
administration site
conditions
Mucosal dryness
Mucosal inflammation
Oedema peripheral
Pain
Pyrexia
Sensation of foreign body
Spinal pain
Swelling
Thirst
Hepatobiliary disorders
n
35
(%)
(87.5)
3
0
0
0
6
0
0
0
1
1
(7.5)
(0.0)
(0.0)
(0.0)
(15.0)
(0.0)
(0.0)
(0.0)
(2.5)
(2.5)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
31
(73.8)
0
0
0
1
7
1
1
0
1
3
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(0.0)
(0.0)
(2.4)
(16.7)
(2.4)
(2.4)
(0.0)
(2.4)
(7.1)
2.7.4
592
-
48-wk PBO + Peg-IFN
+ RBV
n
34
(%)
(82.9)
n
32
(%)
(69.6)
n
31
(%)
(73.8)
0
0
0
2
5
0
0
0
1
2
(0.0)
(0.0)
(0.0)
(4.9)
(12.2)
(0.0)
(0.0)
(0.0)
(2.4)
(4.9)
0
0
1
2
10
0
0
1
0
1
(0.0)
(0.0)
(2.2)
(4.3)
(21.7)
(0.0)
(0.0)
(2.2)
(0.0)
(2.2)
0
1
0
2
10
0
0
0
0
0
(0.0)
(2.4)
(0.0)
(4.8)
(23.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Hepatobiliary disorders
Cholelithiasis
Hepatic cirrhosis
Hepatomegaly
Immune system disorders
Anaphylactic reaction
Drug hypersensitivity
Seasonal allergy
Infections and infestations
Abscess limb
Acute sinusitis
Arthritis infective
n
1
0
0
1
1
0
1
0
12
0
0
0
(%)
(2.5)
(0.0)
(0.0)
(2.5)
(2.5)
(0.0)
(2.5)
(0.0)
(30.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
0
(0.0)
0
(0.0)
3
(7.1)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
21
(50.0)
1
(2.4)
1
(2.4)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
2
1
1
0
0
0
0
0
19
0
0
0
臨床的安全性
-
593
-
(%)
(4.9)
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(46.3)
(0.0)
(0.0)
(0.0)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
1
1
0
0
1
1
0
0
21
0
0
1
(%)
(2.2)
(2.2)
(0.0)
(0.0)
(2.2)
(2.2)
(0.0)
(0.0)
(45.7)
(0.0)
(0.0)
(2.2)
48-wk PBO + Peg-IFN
+ RBV
n
0
0
0
0
0
0
0
0
11
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(26.2)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Infections and infestations
Bronchitis
Candidiasis
Cellulitis
Conjunctivitis infective
Conjunctivitis viral
Cystitis
Diarrhoea infectious
Ear infection
Eczema infected
Folliculitis
Gastroenteritis
Gastroenteritis viral
H1N1 influenza
n
12
2
1
0
0
0
2
0
0
0
1
0
0
1
(%)
(30.0)
(5.0)
(2.5)
(0.0)
(0.0)
(0.0)
(5.0)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
(0.0)
(2.5)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
21
(50.0)
1
(2.4)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
2
(4.8)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.8)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
19
2
1
0
0
0
2
0
1
1
0
1
1
0
臨床的安全性
-
594
-
(%)
(46.3)
(4.9)
(2.4)
(0.0)
(0.0)
(0.0)
(4.9)
(0.0)
(2.4)
(2.4)
(0.0)
(2.4)
(2.4)
(0.0)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
21
2
0
0
1
0
1
1
1
0
0
1
0
0
(%)
(45.7)
(4.3)
(0.0)
(0.0)
(2.2)
(0.0)
(2.2)
(2.2)
(2.2)
(0.0)
(0.0)
(2.2)
(0.0)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
11
1
0
0
0
0
1
0
0
0
0
0
0
0
(%)
(26.2)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Infections and infestations
Herpes ophthalmic
Herpes simplex
Herpes zoster
Hordeolum
Infected bites
Influenza
Intertrigo candida
Localised infection
Lower respiratory tract
infection
Lung infection
Nasopharyngitis
Oral fungal infection
n
12
0
1
0
1
0
0
0
1
0
(%)
(30.0)
(0.0)
(2.5)
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
0
0
1
(0.0)
(0.0)
(2.5)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
21
(50.0)
1
(2.4)
0
(0.0)
1
(2.4)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
1
5
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(2.4)
(11.9)
(0.0)
2.7.4
595
-
48-wk PBO + Peg-IFN
+ RBV
n
19
1
0
1
0
0
1
0
0
0
(%)
(46.3)
(2.4)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
n
21
0
0
0
1
1
1
0
0
0
(%)
(45.7)
(0.0)
(0.0)
(0.0)
(2.2)
(2.2)
(2.2)
(0.0)
(0.0)
(0.0)
n
11
0
0
0
0
0
0
0
0
0
(%)
(26.2)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
3
2
(0.0)
(7.3)
(4.9)
0
4
0
(0.0)
(8.7)
(0.0)
0
2
1
(0.0)
(4.8)
(2.4)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Infections and infestations
Oral herpes
Otitis externa
Otitis media
Pertussis
Pharyngitis
Pharyngitis streptococcal
Pneumonia
Pyelonephritis
Pyelonephritis acute
Rhinitis
Sinusitis
Skin infection
Tinea pedis
n
12
1
1
1
0
0
0
0
0
0
0
2
0
1
(%)
(30.0)
(2.5)
(2.5)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(5.0)
(0.0)
(2.5)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
21
(50.0)
0
(0.0)
2
(4.8)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.8)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
19
1
1
0
0
0
0
0
0
0
2
1
0
0
臨床的安全性
-
596
-
(%)
(46.3)
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(4.9)
(2.4)
(0.0)
(0.0)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
21
3
0
0
1
0
1
0
1
1
0
4
1
0
(%)
(45.7)
(6.5)
(0.0)
(0.0)
(2.2)
(0.0)
(2.2)
(0.0)
(2.2)
(2.2)
(0.0)
(8.7)
(2.2)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
11
3
0
0
0
1
0
0
0
0
1
1
0
0
(%)
(26.2)
(7.1)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Infections and infestations
Tonsillitis
Tooth abscess
Tooth infection
Upper respiratory tract
infection
Urinary tract infection
Urinary tract infection
bacterial
Vaginal infection
Vaginitis bacterial
Viral infection
Vulvovaginal candidiasis
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
21
(50.0)
0
(0.0)
0
(0.0)
1
(2.4)
5
(11.9)
n
12
0
0
0
1
(%)
(30.0)
(0.0)
(0.0)
(0.0)
(2.5)
2
0
(5.0)
(0.0)
1
0
0
0
0
1
(0.0)
(0.0)
(0.0)
(2.5)
0
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
19
0
1
0
2
(%)
(46.3)
(0.0)
(2.4)
(0.0)
(4.9)
n
21
1
0
0
2
(%)
(45.7)
(2.2)
(0.0)
(0.0)
(4.3)
n
11
0
0
0
4
(%)
(26.2)
(0.0)
(0.0)
(0.0)
(9.5)
(2.4)
(0.0)
0
1
(0.0)
(2.4)
2
0
(4.3)
(0.0)
1
0
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
1
0
(0.0)
(0.0)
(2.4)
(0.0)
0
1
0
0
(0.0)
(2.2)
(0.0)
(0.0)
1
0
0
0
(2.4)
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
597
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Infections and infestations
Vulvovaginal mycotic
infection
Wound infection
Injury, poisoning and
procedural complications
Accidental overdose
Animal bite
Burn oesophageal
Carbon monoxide
poisoning
Contusion
Excoriation
Fall
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
21
(50.0)
0
(0.0)
n
12
0
(%)
(30.0)
(0.0)
0
2
(0.0)
(5.0)
1
5
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
0
0
(2.5)
(0.0)
(0.0)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
19
1
(%)
(46.3)
(2.4)
n
21
0
(%)
(45.7)
(0.0)
n
11
0
(%)
(26.2)
(0.0)
(2.4)
(11.9)
0
7
(0.0)
(17.1)
0
6
(0.0)
(13.0)
0
7
(0.0)
(16.7)
1
0
0
0
(2.4)
(0.0)
(0.0)
(0.0)
1
0
1
0
(2.4)
(0.0)
(2.4)
(0.0)
0
0
0
1
(0.0)
(0.0)
(0.0)
(2.2)
1
1
0
0
(2.4)
(2.4)
(0.0)
(0.0)
1
1
1
(2.4)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
2
0
0
(4.3)
(0.0)
(0.0)
0
2
0
(0.0)
(4.8)
(0.0)
2.7.4
臨床的安全性
-
598
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Injury, poisoning and
procedural complications
Femur fracture
Foot fracture
Joint sprain
Laceration
Limb injury
Muscle strain
Overdose
Post-traumatic pain
Road traffic accident
Skeletal injury
Thermal burn
Tongue injury
n
2
(%)
(5.0)
0
0
0
0
0
1
0
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
0
0
0
1
0
0
0
0
1
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
2.7.4
599
-
48-wk PBO + Peg-IFN
+ RBV
n
7
(%)
(17.1)
n
6
(%)
(13.0)
n
7
(%)
(16.7)
1
1
0
0
0
0
1
1
1
0
0
1
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(2.4)
(0.0)
(0.0)
(2.4)
0
0
0
2
0
1
0
0
0
1
0
0
(0.0)
(0.0)
(0.0)
(4.3)
(0.0)
(2.2)
(0.0)
(0.0)
(0.0)
(2.2)
(0.0)
(0.0)
0
0
1
0
1
1
0
0
1
0
1
0
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Investigations
Alanine aminotransferase
increased
Aspartate
aminotransferase
increased
Blood bilirubin increased
Blood creatine
phosphokinase increased
Blood creatinine
increased
Blood lactate
dehydrogenase increased
Blood potassium
increased
Blood thyroid stimulating
hormone decreased
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
0
(0.0)
n
6
0
(%)
(15.0)
(0.0)
0
(0.0)
0
1
0
(2.5)
(0.0)
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
7
1
(%)
(17.1)
(2.4)
n
9
1
(%)
(19.6)
(2.2)
n
3
1
(%)
(7.1)
(2.4)
(0.0)
1
(2.4)
1
(2.2)
1
(2.4)
0
0
(0.0)
(0.0)
0
1
(0.0)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.5)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
600
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Investigations
Blood thyroid stimulating
hormone increased
Blood urine present
Electrocardiogram QT
prolonged
Electrocardiogram T
wave amplitude increased
Gastric pH decreased
Haemoglobin decreased
Liver function test
abnormal
Neutrophil count
decreased
Platelet count decreased
Weight decreased
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
1
(2.4)
n
6
1
(%)
(15.0)
(2.5)
1
0
(2.5)
(0.0)
0
0
0
(0.0)
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
7
0
(%)
(17.1)
(0.0)
n
9
2
(%)
(19.6)
(4.3)
n
3
0
(%)
(7.1)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
1
(0.0)
(2.2)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
(0.0)
(0.0)
(0.0)
0
2
0
(0.0)
(4.8)
(0.0)
1
1
1
(2.4)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
1
0
(0.0)
(2.4)
(0.0)
0
(0.0)
2
(4.8)
1
(2.4)
0
(0.0)
0
(0.0)
0
2
(0.0)
(5.0)
1
0
(2.4)
(0.0)
0
5
(0.0)
(12.2)
1
4
(2.2)
(8.7)
0
1
(0.0)
(2.4)
2.7.4
臨床的安全性
-
601
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Investigations
Weight increased
White blood cell count
decreased
Metabolism and nutrition
disorders
Decreased appetite
Dehydration
Diabetes mellitus
Fat intolerance
Hyperuricaemia
Hypokalaemia
Hypomagnesaemia
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
0
(0.0)
0
(0.0)
n
6
0
0
(%)
(15.0)
(0.0)
(0.0)
9
(22.5)
15
8
0
0
0
0
1
0
(20.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
13
0
0
0
1
1
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
7
0
0
(%)
(17.1)
(0.0)
(0.0)
n
9
1
1
(%)
(19.6)
(2.2)
(2.2)
n
3
0
0
(%)
(7.1)
(0.0)
(0.0)
(35.7)
10
(24.4)
8
(17.4)
3
(7.1)
(31.0)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
8
0
0
1
0
0
1
(19.5)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
5
1
2
0
0
0
0
(10.9)
(2.2)
(4.3)
(0.0)
(0.0)
(0.0)
(0.0)
3
0
0
0
0
0
0
(7.1)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
602
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Metabolism and nutrition
disorders
Type 2 diabetes mellitus
Musculoskeletal and
connective tissue disorders
Amyotrophy
Arthralgia
Back pain
Bone pain
Costochondritis
Flank pain
Muscle fatigue
Muscle spasms
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
15
(35.7)
n
9
(%)
(22.5)
0
18
(0.0)
(45.0)
0
19
0
7
5
1
0
0
0
1
(0.0)
(17.5)
(12.5)
(2.5)
(0.0)
(0.0)
(0.0)
(2.5)
0
6
3
0
1
1
0
2
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
10
(%)
(24.4)
n
8
(%)
(17.4)
n
3
(%)
(7.1)
(0.0)
(45.2)
1
21
(2.4)
(51.2)
0
23
(0.0)
(50.0)
0
21
(0.0)
(50.0)
(0.0)
(14.3)
(7.1)
(0.0)
(2.4)
(2.4)
(0.0)
(4.8)
0
5
3
0
0
0
1
4
(0.0)
(12.2)
(7.3)
(0.0)
(0.0)
(0.0)
(2.4)
(9.8)
1
8
6
0
0
0
0
2
(2.2)
(17.4)
(13.0)
(0.0)
(0.0)
(0.0)
(0.0)
(4.3)
0
7
2
0
0
0
1
1
(0.0)
(16.7)
(4.8)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
2.7.4
臨床的安全性
-
603
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Musculoskeletal and
connective tissue disorders
Muscle twitching
Muscular weakness
Musculoskeletal chest
pain
Musculoskeletal pain
Musculoskeletal stiffness
Myalgia
Myositis
Neck pain
Osteoporosis
Pain in extremity
Periarthritis
Synovial cyst
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
19
(45.2)
n
18
(%)
(45.0)
1
0
0
(2.5)
(0.0)
(0.0)
0
1
1
1
0
4
0
1
0
0
0
0
(2.5)
(0.0)
(10.0)
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
1
0
4
0
3
0
1
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
21
(%)
(51.2)
n
23
(%)
(50.0)
n
21
(%)
(50.0)
(0.0)
(2.4)
(2.4)
0
1
1
(0.0)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
1
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
(9.5)
(0.0)
(7.1)
(0.0)
(2.4)
(0.0)
(0.0)
3
1
13
1
1
1
2
1
1
(7.3)
(2.4)
(31.7)
(2.4)
(2.4)
(2.4)
(4.9)
(2.4)
(2.4)
5
0
11
0
0
0
2
0
0
(10.9)
(0.0)
(23.9)
(0.0)
(0.0)
(0.0)
(4.3)
(0.0)
(0.0)
1
0
9
0
1
0
2
0
0
(2.4)
(0.0)
(21.4)
(0.0)
(2.4)
(0.0)
(4.8)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
604
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Neoplasms benign,
malignant and unspecified
(incl cysts and polyps)
Malignant melanoma
Seborrhoeic keratosis
Nervous system disorders
Ageusia
Amnesia
Carotid arteriosclerosis
Carpal tunnel syndrome
Disturbance in attention
Dizziness
Dizziness postural
n
0
(%)
(0.0)
0
0
19
0
0
0
1
1
3
0
(0.0)
(0.0)
(47.5)
(0.0)
(0.0)
(0.0)
(2.5)
(2.5)
(7.5)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
0
20
0
0
0
0
1
5
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(0.0)
(47.6)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(11.9)
(0.0)
2.7.4
605
-
48-wk PBO + Peg-IFN
+ RBV
n
1
(%)
(2.4)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
1
0
29
1
1
1
0
1
4
1
(2.4)
(0.0)
(70.7)
(2.4)
(2.4)
(2.4)
(0.0)
(2.4)
(9.8)
(2.4)
0
1
21
0
0
0
0
3
7
0
(0.0)
(2.2)
(45.7)
(0.0)
(0.0)
(0.0)
(0.0)
(6.5)
(15.2)
(0.0)
0
0
17
0
0
0
0
1
5
0
(0.0)
(0.0)
(40.5)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(11.9)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Nervous system disorders
Dysgeusia
Headache
Hyperaesthesia
Hypoaesthesia
Lethargy
Memory impairment
Migraine
Neuralgia
Paraesthesia
Parosmia
Presyncope
Restless legs syndrome
Sciatica
n
19
4
16
0
0
0
0
1
0
2
0
1
1
2
(%)
(47.5)
(10.0)
(40.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
(5.0)
(0.0)
(2.5)
(2.5)
(5.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
20
(47.6)
3
(7.1)
11
(26.2)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
1
(2.4)
0
(0.0)
1
(2.4)
1
(2.4)
1
(2.4)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
29
4
21
1
0
1
1
0
0
4
0
1
0
2
臨床的安全性
-
606
-
(%)
(70.7)
(9.8)
(51.2)
(2.4)
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
(9.8)
(0.0)
(2.4)
(0.0)
(4.9)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
21
1
16
0
1
1
1
0
0
1
0
0
0
1
(%)
(45.7)
(2.2)
(34.8)
(0.0)
(2.2)
(2.2)
(2.2)
(0.0)
(0.0)
(2.2)
(0.0)
(0.0)
(0.0)
(2.2)
48-wk PBO + Peg-IFN
+ RBV
n
17
1
13
0
0
0
0
0
1
0
0
0
0
0
(%)
(40.5)
(2.4)
(31.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Nervous system disorders
Sinus headache
Somnolence
Syncope
Tension headache
Psychiatric disorders
Abnormal dreams
Affect lability
Affective disorder
Aggression
Anxiety
Apathy
Bruxism
n
19
0
0
0
0
19
1
1
0
0
4
0
0
(%)
(47.5)
(0.0)
(0.0)
(0.0)
(0.0)
(47.5)
(2.5)
(2.5)
(0.0)
(0.0)
(10.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
20
(47.6)
0
(0.0)
1
(2.4)
2
(4.8)
0
(0.0)
20
(47.6)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
3
(7.1)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
29
1
0
2
0
24
0
0
0
1
1
1
1
臨床的安全性
-
607
-
(%)
(70.7)
(2.4)
(0.0)
(4.9)
(0.0)
(58.5)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(2.4)
(2.4)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
21
0
0
0
1
25
1
0
1
0
2
1
0
(%)
(45.7)
(0.0)
(0.0)
(0.0)
(2.2)
(54.3)
(2.2)
(0.0)
(2.2)
(0.0)
(4.3)
(2.2)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
17
0
1
0
1
17
0
0
0
2
1
0
0
(%)
(40.5)
(0.0)
(2.4)
(0.0)
(2.4)
(40.5)
(0.0)
(0.0)
(0.0)
(4.8)
(2.4)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Psychiatric disorders
Completed suicide
Depressed mood
Depression
Dysthymic disorder
Emotional disorder
Insomnia
Libido decreased
Libido disorder
Loss of libido
Major depression
Mood altered
Mood swings
Nervousness
n
19
1
1
3
1
0
7
0
0
0
1
0
2
0
(%)
(47.5)
(2.5)
(2.5)
(7.5)
(2.5)
(0.0)
(17.5)
(0.0)
(0.0)
(0.0)
(2.5)
(0.0)
(5.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
20
(47.6)
0
(0.0)
3
(7.1)
7
(16.7)
0
(0.0)
0
(0.0)
7
(16.7)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.8)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
24
0
6
9
1
0
12
1
0
1
0
0
0
2
臨床的安全性
-
608
-
(%)
(58.5)
(0.0)
(14.6)
(22.0)
(2.4)
(0.0)
(29.3)
(2.4)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(4.9)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
25
0
2
9
0
1
6
0
1
0
1
0
1
0
(%)
(54.3)
(0.0)
(4.3)
(19.6)
(0.0)
(2.2)
(13.0)
(0.0)
(2.2)
(0.0)
(2.2)
(0.0)
(2.2)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
17
0
3
1
0
0
10
0
0
0
0
1
0
0
(%)
(40.5)
(0.0)
(7.1)
(2.4)
(0.0)
(0.0)
(23.8)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Psychiatric disorders
Panic attack
Sleep disorder
Suicidal ideation
Renal and urinary disorders
Chromaturia
Dysuria
Haematuria
Micturition urgency
Nephrolithiasis
Nocturia
Pollakiuria
Polyuria
n
19
0
7
1
2
0
1
0
1
0
0
0
0
(%)
(47.5)
(0.0)
(17.5)
(2.5)
(5.0)
(0.0)
(2.5)
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
20
(47.6)
0
(0.0)
5
(11.9)
0
(0.0)
2
(4.8)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
n
24
0
4
1
4
0
0
0
0
0
0
2
2
臨床的安全性
-
609
-
(%)
(58.5)
(0.0)
(9.8)
(2.4)
(9.8)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(4.9)
(4.9)
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
n
25
1
8
0
2
0
0
1
0
1
0
0
0
(%)
(54.3)
(2.2)
(17.4)
(0.0)
(4.3)
(0.0)
(0.0)
(2.2)
(0.0)
(2.2)
(0.0)
(0.0)
(0.0)
48-wk PBO + Peg-IFN
+ RBV
n
17
0
4
0
3
0
1
0
0
1
0
1
0
(%)
(40.5)
(0.0)
(9.5)
(0.0)
(7.1)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Renal and urinary disorders
Urethral pain
Urinary retention
Reproductive system and
breast disorders
Erectile dysfunction
Menorrhagia
Menstrual discomfort
Metrorrhagia
Ovarian cyst
Vaginal haemorrhage
Vulvovaginal pruritus
n
2
0
0
0
(%)
(5.0)
(0.0)
(0.0)
(0.0)
0
0
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
2
(4.8)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
0
0
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
610
-
48-wk PBO + Peg-IFN
+ RBV
n
4
0
0
5
(%)
(9.8)
(0.0)
(0.0)
(12.2)
n
2
1
1
3
(%)
(4.3)
(2.2)
(2.2)
(6.5)
n
3
0
0
0
(%)
(7.1)
(0.0)
(0.0)
(0.0)
2
1
0
1
1
1
1
(4.9)
(2.4)
(0.0)
(2.4)
(2.4)
(2.4)
(2.4)
1
0
1
0
0
0
1
(2.2)
(0.0)
(2.2)
(0.0)
(0.0)
(0.0)
(2.2)
0
0
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Respiratory, thoracic and
mediastinal disorders
Asthma
Cough
Dry throat
Dysphonia
Dyspnoea
Dyspnoea exertional
Epistaxis
Haemoptysis
Increased viscosity of
bronchial secretion
Nasal congestion
Nasal dryness
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
22
(52.4)
n
13
(%)
(32.5)
0
5
0
0
2
2
3
0
0
(0.0)
(12.5)
(0.0)
(0.0)
(5.0)
(5.0)
(7.5)
(0.0)
(0.0)
0
14
0
0
6
3
1
1
0
0
1
(0.0)
(2.5)
1
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
18
(%)
(43.9)
n
19
(%)
(41.3)
n
16
(%)
(38.1)
(0.0)
(33.3)
(0.0)
(0.0)
(14.3)
(7.1)
(2.4)
(2.4)
(0.0)
0
5
1
1
7
1
3
0
0
(0.0)
(12.2)
(2.4)
(2.4)
(17.1)
(2.4)
(7.3)
(0.0)
(0.0)
0
13
2
0
7
3
2
0
1
(0.0)
(28.3)
(4.3)
(0.0)
(15.2)
(6.5)
(4.3)
(0.0)
(2.2)
1
11
0
0
4
0
1
0
0
(2.4)
(26.2)
(0.0)
(0.0)
(9.5)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(0.0)
0
1
(0.0)
(2.4)
0
0
(0.0)
(0.0)
1
0
(2.4)
(0.0)
2.7.4
臨床的安全性
-
611
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Respiratory, thoracic and
mediastinal disorders
Nocturnal dyspnoea
Oropharyngeal pain
Painful respiration
Pleural effusion
Productive cough
Rhinitis allergic
Rhinorrhoea
Throat irritation
Upper respiratory tract
congestion
Vocal cord inflammation
Wheezing
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
22
(52.4)
n
13
(%)
(32.5)
0
2
1
0
1
0
0
0
1
(0.0)
(5.0)
(2.5)
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(2.5)
0
1
0
0
0
0
0
0
0
0
0
(0.0)
(0.0)
1
1
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
18
(%)
(43.9)
n
19
(%)
(41.3)
n
16
(%)
(38.1)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
1
3
0
1
1
0
1
1
0
(2.4)
(7.3)
(0.0)
(2.4)
(2.4)
(0.0)
(2.4)
(2.4)
(0.0)
0
5
0
0
0
0
2
0
0
(0.0)
(10.9)
(0.0)
(0.0)
(0.0)
(0.0)
(4.3)
(0.0)
(0.0)
0
2
0
0
0
1
0
0
0
(0.0)
(4.8)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
1
(0.0)
(2.4)
2.7.4
臨床的安全性
-
612
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Respiratory, thoracic and
mediastinal disorders
Yawning
Skin and subcutaneous
tissue disorders
Alopecia
Blister
Chloasma
Dermal cyst
Dermatitis
Dermatitis allergic
Dermatomyositis
Drug eruption
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
22
(52.4)
n
13
(%)
(32.5)
0
23
(0.0)
(57.5)
0
26
6
0
0
1
2
1
0
0
(15.0)
(0.0)
(0.0)
(2.5)
(5.0)
(2.5)
(0.0)
(0.0)
4
2
0
0
2
0
0
1
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
18
(%)
(43.9)
n
19
(%)
(41.3)
n
16
(%)
(38.1)
(0.0)
(61.9)
1
26
(2.4)
(63.4)
0
33
(0.0)
(71.7)
0
21
(0.0)
(50.0)
(9.5)
(4.8)
(0.0)
(0.0)
(4.8)
(0.0)
(0.0)
(2.4)
8
0
1
0
4
0
1
0
(19.5)
(0.0)
(2.4)
(0.0)
(9.8)
(0.0)
(2.4)
(0.0)
8
0
0
0
3
1
0
0
(17.4)
(0.0)
(0.0)
(0.0)
(6.5)
(2.2)
(0.0)
(0.0)
3
0
1
0
0
0
0
0
(7.1)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
613
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Skin and subcutaneous
tissue disorders
Dry skin
Ecchymosis
Eczema
Erythema
Hair disorder
Hyperhidrosis
Hyperkeratosis
Increased tendency to
bruise
Madarosis
Nail discolouration
Nail disorder
Night sweats
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
26
(61.9)
n
23
(%)
(57.5)
8
0
2
0
0
0
0
0
(20.0)
(0.0)
(5.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
5
1
3
0
0
2
0
0
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO + Peg-IFN
+ RBV
n
26
(%)
(63.4)
n
33
(%)
(71.7)
n
21
(%)
(50.0)
(11.9)
(2.4)
(7.1)
(0.0)
(0.0)
(4.8)
(0.0)
(0.0)
5
0
4
1
0
3
0
0
(12.2)
(0.0)
(9.8)
(2.4)
(0.0)
(7.3)
(0.0)
(0.0)
7
0
5
0
1
1
0
1
(15.2)
(0.0)
(10.9)
(0.0)
(2.2)
(2.2)
(0.0)
(2.2)
6
0
5
0
0
1
1
0
(14.3)
(0.0)
(11.9)
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
1
0
0
2
(2.4)
(0.0)
(0.0)
(4.9)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
1
1
0
(0.0)
(2.4)
(2.4)
(0.0)
2.7.4
臨床的安全性
-
614
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Skin and subcutaneous
tissue disorders
Onychoclasis
Pain of skin
Papule
Photosensitivity reaction
Pruritus
Pruritus generalised
Purpura
Rash
Rash erythematous
Rash papular
Rash pruritic
Seborrhoeic dermatitis
n
23
(%)
(57.5)
0
0
1
0
14
2
0
6
0
0
0
0
(0.0)
(0.0)
(2.5)
(0.0)
(35.0)
(5.0)
(0.0)
(15.0)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
26
(61.9)
0
0
0
3
13
2
0
6
0
2
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(0.0)
(0.0)
(7.1)
(31.0)
(4.8)
(0.0)
(14.3)
(0.0)
(4.8)
(0.0)
(0.0)
2.7.4
615
-
48-wk PBO + Peg-IFN
+ RBV
n
26
(%)
(63.4)
n
33
(%)
(71.7)
n
21
(%)
(50.0)
0
0
0
0
12
1
0
6
0
1
1
0
(0.0)
(0.0)
(0.0)
(0.0)
(29.3)
(2.4)
(0.0)
(14.6)
(0.0)
(2.4)
(2.4)
(0.0)
2
1
0
0
14
1
1
14
0
0
2
0
(4.3)
(2.2)
(0.0)
(0.0)
(30.4)
(2.2)
(2.2)
(30.4)
(0.0)
(0.0)
(4.3)
(0.0)
0
1
0
0
9
2
0
8
2
1
0
1
(0.0)
(2.4)
(0.0)
(0.0)
(21.4)
(4.8)
(0.0)
(19.0)
(4.8)
(2.4)
(0.0)
(2.4)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Skin and subcutaneous
tissue disorders
Skin exfoliation
Skin fissures
Skin induration
Skin ulcer
Swelling face
Trichorrhexis
Urticaria
Urticaria physical
Vitiligo
Xeroderma
Vascular disorders
n
23
(%)
(57.5)
0
1
0
0
0
0
0
0
0
0
0
(0.0)
(2.5)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
26
(61.9)
0
2
1
0
0
0
1
0
0
1
3
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
(0.0)
(4.8)
(2.4)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(2.4)
(7.1)
2.7.4
616
-
48-wk PBO + Peg-IFN
+ RBV
n
26
(%)
(63.4)
n
33
(%)
(71.7)
n
21
(%)
(50.0)
1
0
0
1
1
1
0
1
0
1
4
(2.4)
(0.0)
(0.0)
(2.4)
(2.4)
(2.4)
(0.0)
(2.4)
(0.0)
(2.4)
(9.8)
0
1
0
0
0
0
1
0
1
2
5
(0.0)
(2.2)
(0.0)
(0.0)
(0.0)
(0.0)
(2.2)
(0.0)
(2.2)
(4.3)
(10.9)
0
0
0
0
0
0
1
0
0
0
1
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
(2.4)
臨床的安全性
-
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:32
有害事象発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
48-wk MK-7009 300
48-wk MK-7009 600
48-wk PBO + Peg-IFN
mg bid + Peg-IFN +
mg bid + Peg-IFN +
mg bid + Peg-IFN +
+ RBV
RBV / 24-wk PBO +
RBV
RBV
Peg-IFN + RBV
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
Vascular disorders
0
(0.0)
3
(7.1)
4
(9.8)
5
(10.9)
1
(2.4)
Flushing
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.3)
0
(0.0)
Haematoma
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
Hot flush
0
(0.0)
1
(2.4)
1
(2.4)
1
(2.2)
0
(0.0)
Hypertension
0
(0.0)
1
(2.4)
2
(4.9)
0
(0.0)
1
(2.4)
Orthostatic hypotension
0
(0.0)
0
(0.0)
1
(2.4)
1
(2.2)
0
(0.0)
Varicose vein
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
Every patient is counted a single time for each applicable row and column.
A system organ class or specific adverse event appears on this report only if its incidence in one or more of the columns meets the incidence criterion in the report
title, after rounding.
2.7.4
臨床的安全性
-
617
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）
Placebo + Peg-IFN +
Ribavirin
Patients in population
With one or more
drug-related adverse events
Blood and lymphatic
system disorders
Anaemia
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
18
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
20
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
18
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
19
Relationship
n
19
(%)
Overall
15
(78.9)
15
(83.3)
18
(90.0)
15
(83.3)
17
(89.5)
MK
P+R
MK+P+R
4
15
8
(21.1)
(78.9)
(42.1)
3
13
8
(16.7)
(72.2)
(44.4)
5
14
11
(25.0)
(70.0)
(55.0)
3
12
12
(16.7)
(66.7)
(66.7)
6
15
8
(31.6)
(78.9)
(42.1)
Overall
3
(15.8)
2
(11.1)
2
(10.0)
0
(0.0)
4
(21.1)
P+R
MK+P+R
3
0
(15.8)
(0.0)
2
0
(11.1)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
4
0
(21.1)
(0.0)
Overall
P+R
2
2
(10.5)
(10.5)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
618
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
1
(5.3)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Neutropenia
Overall
P+R
MK+P+R
1
1
0
(5.3)
(5.3)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
2
1
1
(10.0)
(5.0)
(5.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
2
0
(10.5)
(10.5)
(0.0)
Pancytopenia
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Cardiac disorders
Overall
P+R
MK+P+R
1
1
0
(5.3)
(5.3)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.0)
(5.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.3)
(0.0)
(5.3)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Leukopenia
Angina pectoris
2.7.4
臨床的安全性
-
619
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
1
(5.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
0
(0.0)
1
(5.3)
Relationship
Overall
P+R
MK+P+R
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Eye disorders
Overall
P+R
MK+P+R
4
3
2
(21.1)
(15.8)
(10.5)
3
2
1
(16.7)
(11.1)
(5.6)
2
2
0
(10.0)
(10.0)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
2
2
0
(10.5)
(10.5)
(0.0)
Dry eye
Overall
P+R
MK+P+R
1
0
1
(5.3)
(0.0)
(5.3)
1
1
0
(5.6)
(5.6)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
Overall
1
(5.3)
1
(5.6)
1
(5.0)
0
(0.0)
1
(5.3)
Palpitations
Tachycardia
Eye irritation
2.7.4
臨床的安全性
-
620
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
0
(0.0)
Relationship
P+R
MK+P+R
n
1
0
(%)
(5.3)
(0.0)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Eye pruritus
Overall
MK+P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Eye swelling
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
Eye irritation
Eye pain
Photopsia
Vision blurred
2.7.4
臨床的安全性
-
621
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
Relationship
P+R
n
0
(%)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Gastrointestinal disorders
Overall
MK
P+R
MK+P+R
12
2
6
6
(63.2)
(10.5)
(31.6)
(31.6)
11
2
3
7
(61.1)
(11.1)
(16.7)
(38.9)
13
5
5
8
(65.0)
(25.0)
(25.0)
(40.0)
9
2
2
7
(50.0)
(11.1)
(11.1)
(38.9)
11
5
4
6
(57.9)
(26.3)
(21.1)
(31.6)
Abdominal discomfort
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Abdominal pain
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
1
(5.0)
(5.0)
(5.0)
1
0
1
(5.6)
(0.0)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
Vision blurred
Xerophthalmia
2.7.4
臨床的安全性
-
622
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
0
(0.0)
0
(0.0)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
2
(10.0)
1
(5.0)
0
(0.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
0
(0.0)
1
(5.6)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
0
(0.0)
0
(0.0)
1
(5.3)
Relationship
Overall
MK
P+R
MK+P+R
n
1
0
1
0
(%)
(5.3)
(0.0)
(5.3)
(0.0)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Diarrhoea
Overall
MK
P+R
MK+P+R
4
1
1
2
(21.1)
(5.3)
(5.3)
(10.5)
1
0
0
1
(5.6)
(0.0)
(0.0)
(5.6)
6
1
3
2
(30.0)
(5.0)
(15.0)
(10.0)
2
0
0
2
(11.1)
(0.0)
(0.0)
(11.1)
3
1
1
1
(15.8)
(5.3)
(5.3)
(5.3)
Dry mouth
Overall
MK
P+R
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
2
0
2
(10.0)
(0.0)
(10.0)
2
1
1
(11.1)
(5.6)
(5.6)
1
0
0
(5.3)
(0.0)
(0.0)
Abdominal pain upper
Constipation
2.7.4
臨床的安全性
-
623
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
Relationship
MK+P+R
n
0
(%)
(0.0)
Dyspepsia
Overall
MK
P+R
MK+P+R
4
1
1
2
(21.1)
(5.3)
(5.3)
(10.5)
3
2
0
1
(16.7)
(11.1)
(0.0)
(5.6)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
0
0
1
(5.6)
(0.0)
(0.0)
(5.6)
3
2
1
0
(15.8)
(10.5)
(5.3)
(0.0)
Flatulence
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
1
(5.3)
2
(11.1)
0
(0.0)
1
(5.6)
0
(0.0)
P+R
MK+P+R
0
1
(0.0)
(5.3)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
1
(0.0)
(5.6)
0
0
(0.0)
(0.0)
Overall
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
Dry mouth
Gastrooesophageal
reflux disease
Glossodynia
2.7.4
臨床的安全性
-
624
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Lip dry
Overall
MK+P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Nausea
Overall
MK
P+R
MK+P+R
5
0
3
2
(26.3)
(0.0)
(15.8)
(10.5)
4
0
2
2
(22.2)
(0.0)
(11.1)
(11.1)
7
3
1
4
(35.0)
(15.0)
(5.0)
(20.0)
6
1
1
4
(33.3)
(5.6)
(5.6)
(22.2)
6
1
2
3
(31.6)
(5.3)
(10.5)
(15.8)
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Overall
MK+P+R
1
1
(5.3)
(5.3)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Glossodynia
Oesophageal pain
Stomatitis
2.7.4
臨床的安全性
-
625
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
Vomiting
General disorders and
administration site
conditions
Asthenia
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
6
(30.0)
3
(15.0)
2
(10.0)
2
(10.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
3
(16.7)
1
(5.6)
0
(0.0)
2
(11.1)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
2
(10.5)
1
(5.3)
0
(0.0)
1
(5.3)
Relationship
Overall
MK
P+R
MK+P+R
n
0
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
Overall
10
(52.6)
8
(44.4)
11
(55.0)
10
(55.6)
10
(52.6)
MK
P+R
MK+P+R
0
9
3
(0.0)
(47.4)
(15.8)
0
7
1
(0.0)
(38.9)
(5.6)
0
11
1
(0.0)
(55.0)
(5.0)
0
9
1
(0.0)
(50.0)
(5.6)
1
9
1
(5.3)
(47.4)
(5.3)
Overall
P+R
MK+P+R
2
1
1
(10.5)
(5.3)
(5.3)
1
1
0
(5.6)
(5.6)
(0.0)
2
2
0
(10.0)
(10.0)
(0.0)
3
3
0
(16.7)
(16.7)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
2.7.4
臨床的安全性
-
626
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
Chest pain
Chills
Discomfort
Fatigue
Feeling cold
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
1
(5.3)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
P+R
MK+P+R
2
2
0
(10.5)
(10.5)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
1
1
0
(5.0)
(5.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
3
3
0
(15.8)
(15.8)
(0.0)
Overall
MK
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Overall
P+R
MK+P+R
6
4
2
(31.6)
(21.1)
(10.5)
3
3
0
(16.7)
(16.7)
(0.0)
6
5
1
(30.0)
(25.0)
(5.0)
2
2
0
(11.1)
(11.1)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
2.7.4
臨床的安全性
-
627
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
P+R
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
Overall
P+R
MK+P+R
4
4
0
(21.1)
(21.1)
(0.0)
4
4
0
(22.2)
(22.2)
(0.0)
4
4
0
(20.0)
(20.0)
(0.0)
4
3
1
(22.2)
(16.7)
(5.6)
5
5
0
(26.3)
(26.3)
(0.0)
Injection site erythema
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
2
2
(10.0)
(10.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
Injection site reaction
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Irritability
Overall
P+R
2
2
(10.5)
(10.5)
2
2
(11.1)
(11.1)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Feeling of body
temperature change
Influenza like illness
2.7.4
臨床的安全性
-
628
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
3
(15.0)
2
(10.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
1
1
(5.6)
(5.6)
3
3
(15.8)
(15.8)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
1
1
0
(5.0)
(5.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
Bronchitis
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Herpes virus infection
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Pain
Pyrexia
Infections and infestations
2.7.4
臨床的安全性
-
629
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
P+R
MK+P+R
2
1
1
(10.5)
(5.3)
(5.3)
3
2
1
(16.7)
(11.1)
(5.6)
3
2
1
(15.0)
(10.0)
(5.0)
2
2
0
(11.1)
(11.1)
(0.0)
2
2
0
(10.5)
(10.5)
(0.0)
Overall
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
MK+P+R
0
(0.0)
0
(0.0)
1
(5.0)
0
(0.0)
0
(0.0)
Body temperature
increased
Overall
1
(5.3)
1
(5.6)
0
(0.0)
1
(5.6)
1
(5.3)
P+R
1
(5.3)
1
(5.6)
0
(0.0)
1
(5.6)
1
(5.3)
Haemoglobin decreased
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
Viral infection
Investigations
Blood bilirubin
increased
2.7.4
臨床的安全性
-
630
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
P+R
MK+P+R
0
0
(0.0)
(0.0)
0
1
(0.0)
(5.6)
1
0
(5.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
P+R
MK+P+R
1
0
1
(5.3)
(0.0)
(5.3)
0
0
0
(0.0)
(0.0)
(0.0)
2
2
0
(10.0)
(10.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
White blood cell count
decreased
Overall
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
1
(5.3)
P+R
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
1
(5.3)
Metabolism and nutrition
disorders
Overall
2
(10.5)
3
(16.7)
5
(25.0)
1
(5.6)
1
(5.3)
P+R
MK+P+R
2
1
(10.5)
(5.3)
2
1
(11.1)
(5.6)
4
1
(20.0)
(5.0)
0
1
(0.0)
(5.6)
0
1
(0.0)
(5.3)
Neutrophil count
decreased
Weight decreased
2.7.4
臨床的安全性
-
631
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
3
(16.7)
2
(11.1)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
5
(25.0)
4
(20.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
0
(0.0)
1
(5.6)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
0
(0.0)
1
(5.3)
Relationship
Overall
P+R
MK+P+R
n
2
2
1
(%)
(10.5)
(10.5)
(5.3)
Overall
3
(15.8)
5
(27.8)
2
(10.0)
3
(16.7)
2
(10.5)
MK
P+R
MK+P+R
0
3
0
(0.0)
(15.8)
(0.0)
1
3
1
(5.6)
(16.7)
(5.6)
0
2
0
(0.0)
(10.0)
(0.0)
0
2
1
(0.0)
(11.1)
(5.6)
0
2
0
(0.0)
(10.5)
(0.0)
Arthralgia
Overall
MK
P+R
0
0
0
(0.0)
(0.0)
(0.0)
3
1
2
(16.7)
(5.6)
(11.1)
2
0
2
(10.0)
(0.0)
(10.0)
1
0
1
(5.6)
(0.0)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
Back pain
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
2
2
(10.5)
(10.5)
Decreased appetite
Musculoskeletal and
connective tissue disorders
2.7.4
臨床的安全性
-
632
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
1
1
(%)
(5.3)
(5.3)
Overall
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
P+R
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(11.1)
(5.6)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(11.1)
(5.6)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
Myalgia
Overall
P+R
2
2
(10.5)
(10.5)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
Pain in extremity
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Muscular weakness
Musculoskeletal chest
pain
Musculoskeletal pain
2.7.4
臨床的安全性
-
633
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
5
(27.8)
0
(0.0)
2
(11.1)
3
(16.7)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
9
(45.0)
0
(0.0)
7
(35.0)
2
(10.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
10
(55.6)
0
(0.0)
3
(16.7)
7
(38.9)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
5
(26.3)
1
(5.3)
2
(10.5)
2
(10.5)
Relationship
Overall
MK
P+R
MK+P+R
n
6
0
4
2
(%)
(31.6)
(0.0)
(21.1)
(10.5)
Disturbance in attention
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Dizziness
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Dysgeusia
Overall
MK
P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
1
1
0
(5.3)
(5.3)
(0.0)
Headache
Overall
6
(31.6)
3
(16.7)
8
(40.0)
7
(38.9)
2
(10.5)
Nervous system disorders
2.7.4
臨床的安全性
-
634
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
2
(11.1)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
7
(35.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
2
(11.1)
5
(27.8)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
2
(10.5)
Relationship
P+R
MK+P+R
n
4
2
(%)
(21.1)
(10.5)
Hyperaesthesia
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Memory impairment
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Paraesthesia
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Restless legs syndrome
Overall
1
(5.3)
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.3)
Headache
Migraine
2.7.4
臨床的安全性
-
635
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
1
(5.3)
Relationship
P+R
MK+P+R
n
1
0
(%)
(5.3)
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
0
2
(11.1)
(0.0)
(11.1)
1
1
0
(5.3)
(5.3)
(0.0)
Psychiatric disorders
Overall
P+R
MK+P+R
5
3
3
(26.3)
(15.8)
(15.8)
5
4
2
(27.8)
(22.2)
(11.1)
2
2
0
(10.0)
(10.0)
(0.0)
5
4
1
(27.8)
(22.2)
(5.6)
4
3
1
(21.1)
(15.8)
(5.3)
Abnormal dreams
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Restless legs syndrome
Somnolence
Anxiety
2.7.4
臨床的安全性
-
636
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Depression
Overall
P+R
MK+P+R
2
2
0
(10.5)
(10.5)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
1
1
0
(5.0)
(5.0)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
Initial insomnia
Overall
MK+P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Insomnia
Overall
P+R
MK+P+R
2
1
1
(10.5)
(5.3)
(5.3)
4
4
0
(22.2)
(22.2)
(0.0)
1
1
0
(5.0)
(5.0)
(0.0)
3
2
1
(16.7)
(11.1)
(5.6)
2
2
0
(10.5)
(10.5)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Depressed mood
Libido decreased
2.7.4
臨床的安全性
-
637
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
1
(5.6)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Nervousness
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Restlessness
Overall
MK+P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Sleep disorder
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Renal and urinary
disorders
Overall
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
MK+P+R
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
Overall
0
(0.0)
1
(5.6)
0
(0.0)
0
(0.0)
0
(0.0)
Mood swings
Pollakiuria
2.7.4
臨床的安全性
-
638
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
0
(0.0)
1
(5.6)
1
(5.0)
0
(0.0)
0
(0.0)
P+R
MK+P+R
0
0
(0.0)
(0.0)
1
0
(5.6)
(0.0)
0
1
(0.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Erectile dysfunction
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Menstrual disorder
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Respiratory, thoracic and
mediastinal disorders
Overall
2
(10.5)
2
(11.1)
1
(5.0)
3
(16.7)
2
(10.5)
P+R
2
(10.5)
1
(5.6)
1
(5.0)
3
(16.7)
1
(5.3)
Pollakiuria
Reproductive system and
breast disorders
2.7.4
臨床的安全性
-
639
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.3)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.6)
(0.0)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
Dry throat
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
Dyspnoea
Overall
P+R
MK+P+R
2
2
0
(10.5)
(10.5)
(0.0)
2
1
1
(11.1)
(5.6)
(5.6)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
Epistaxis
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Respiratory, thoracic and
mediastinal disorders
Cough
2.7.4
臨床的安全性
-
640
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.0)
(5.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(5.3)
(0.0)
(5.3)
Productive cough
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Rhinorrhoea
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Throat irritation
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
Nasal dryness
Oropharyngeal pain
2.7.4
臨床的安全性
-
641
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
7
(38.9)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
4
(20.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
4
(22.2)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
5
(26.3)
Relationship
Overall
n
7
(%)
(36.8)
MK
P+R
MK+P+R
2
6
1
(10.5)
(31.6)
(5.3)
1
5
2
(5.6)
(27.8)
(11.1)
0
3
1
(0.0)
(15.0)
(5.0)
1
3
0
(5.6)
(16.7)
(0.0)
0
5
0
(0.0)
(26.3)
(0.0)
Alopecia
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Dry skin
Overall
P+R
3
3
(15.8)
(15.8)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
1
1
(5.3)
(5.3)
Eczema
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Erythema
Overall
1
(5.3)
1
(5.6)
0
(0.0)
1
(5.6)
0
(0.0)
Skin and subcutaneous
tissue disorders
2.7.4
臨床的安全性
-
642
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
Relationship
MK
n
1
(%)
(5.3)
Overall
P+R
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Pruritus
Overall
P+R
MK+P+R
3
2
1
(15.8)
(10.5)
(5.3)
2
2
0
(11.1)
(11.1)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(5.6)
(5.6)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
Rash
Overall
P+R
MK+P+R
2
1
1
(10.5)
(5.3)
(5.3)
2
0
2
(11.1)
(0.0)
(11.1)
2
2
0
(10.0)
(10.0)
(0.0)
2
2
0
(11.1)
(11.1)
(0.0)
1
1
0
(5.3)
(5.3)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
1
1
(5.6)
(5.6)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.3)
(5.3)
Erythema
Night sweats
Rash papular
2.7.4
臨床的安全性
-
643
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
1
(5.0)
1
(5.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Skin burning sensation
Overall
P+R
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(5.0)
(5.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Skin reaction
Overall
MK
1
1
(5.3)
(5.3)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
Rash vesicular
2.7.4
臨床的安全性
-
644
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:33
副作用発現例数（007 試験）（治療期+後観察期［14 日間］）（続き）
Placebo + Peg-IFN +
Ribavirin
Vascular disorders
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
MK-7009 300 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Hot flush
MK-7009 600 mg
bid + Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
MK-7009 600 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
1
(5.6)
1
(5.6)
MK-7009 800 mg qd
+ Peg-IFN +
Ribavirin
n
(%)
0
(0.0)
0
(0.0)
Overall
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
P+R
0
(0.0)
0
(0.0)
0
(0.0)
1
(5.6)
0
(0.0)
Every patient is counted once on each applicable row.
A system organ class or specific adverse event appears on this report only if its incidence in one or more of the columns is greater than or equal to the percent
incidence specified in the report title, after rounding.
Relationship: study medication(s) to which the investigator attributed the adverse event. MK = MK-7009/PLACEBO, P+R = PEG-IFN AND RIBAVIRIN,
MK+P+R = MK-7009/PLACEBO AND PEG-IFN AND RIBAVIRIN.
Relationship P+R signifies the adverse event was attributed to one or more of the following: peg-IFN or ribavirin.
Relationship MK+P+R signifies the adverse event was attributed to one or more of the following: MK-7009/placebo or peg-IFN or ribavirin.
2.7.4
臨床的安全性
-
645
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34 副作用発現例数（009 試験：非肝硬変患者）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Patients in population
With one or more
drug-related adverse events
Blood and lymphatic
system disorders
Anaemia
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
42
Relationship
n
40
(%)
Overall
36
(90.0)
41
MK
P+R
MK+P+R
16
30
29
(40.0)
(75.0)
(72.5)
Overall
9
P+R
MK+P+R
Overall
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
41
(%)
n
46
(%)
n
42
(%)
(97.6)
40
(97.6)
45
(97.8)
35
(83.3)
11
36
33
(26.2)
(85.7)
(78.6)
13
35
31
(31.7)
(85.4)
(75.6)
15
39
40
(32.6)
(84.8)
(87.0)
5
31
21
(11.9)
(73.8)
(50.0)
(22.5)
12
(28.6)
12
(29.3)
12
(26.1)
8
(19.0)
6
3
(15.0)
(7.5)
10
2
(23.8)
(4.8)
10
2
(24.4)
(4.9)
11
1
(23.9)
(2.2)
7
1
(16.7)
(2.4)
4
(10.0)
8
(19.0)
7
(17.1)
5
(10.9)
7
(16.7)
2.7.4
臨床的安全性
-
646
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
6
(14.3)
2
(4.8)
Relationship
P+R
MK+P+R
n
4
0
(%)
(10.0)
(0.0)
Anisocytosis
Overall
P+R
0
0
(0.0)
(0.0)
1
1
Leukopenia
Overall
P+R
2
2
(5.0)
(5.0)
Lymphadenopathy
Overall
P+R
0
0
Neutropenia
Overall
P+R
7
5
Anaemia
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
6
1
(%)
(14.6)
(2.4)
n
4
1
(%)
(8.7)
(2.2)
n
7
0
(%)
(16.7)
(0.0)
(2.4)
(2.4)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.8)
(4.8)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(17.5)
(12.5)
5
5
(11.9)
(11.9)
3
2
(7.3)
(4.9)
8
8
(17.4)
(17.4)
2
1
(4.8)
(2.4)
2.7.4
臨床的安全性
-
647
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
2
(%)
(5.0)
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
0
0
0
Cardiac disorders
Overall
MK+P+R
2
2
(5.0)
(5.0)
Bradycardia
Overall
MK+P+R
1
1
Palpitations
Overall
MK+P+R
1
1
Neutropenia
Thrombocytopenia
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
1
(%)
(2.4)
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
1
1
0
(2.4)
(2.4)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.3)
(4.3)
0
0
(0.0)
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.3)
(4.3)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
648
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Congenital, familial and
genetic disorders
Ichthyosis
Ear and labyrinth disorders
Ear pain
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
P+R
0
(0.0)
0
Overall
P+R
0
0
(0.0)
(0.0)
Overall
P+R
MK+P+R
2
0
2
Overall
MK+P+R
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(5.0)
(0.0)
(5.0)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
0
(2.4)
(2.4)
(0.0)
4
0
4
(8.7)
(0.0)
(8.7)
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.3)
(4.3)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
649
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Tinnitus
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Vertigo
Overall
P+R
MK+P+R
2
0
2
(5.0)
(0.0)
(5.0)
Overall
P+R
1
1
Overall
0
Hyperacusis
Endocrine disorders
Autoimmune thyroiditis
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
1
1
(%)
(2.2)
(2.2)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
(2.5)
(2.5)
2
2
(4.8)
(4.8)
1
1
(2.4)
(2.4)
4
4
(8.7)
(8.7)
1
1
(2.4)
(2.4)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
650
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
P+R
n
0
(%)
(0.0)
Hyperthyroidism
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Hypothyroidism
Overall
P+R
1
1
(2.5)
(2.5)
Overall
P+R
MK+P+R
4
1
4
Overall
MK+P+R
3
3
Autoimmune thyroiditis
Eye disorders
Conjunctivitis
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.3)
(4.3)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
1
1
(2.4)
(2.4)
3
3
(6.5)
(6.5)
1
1
(2.4)
(2.4)
(10.0)
(2.5)
(10.0)
2
1
1
(4.8)
(2.4)
(2.4)
7
5
2
(17.1)
(12.2)
(4.9)
5
3
2
(10.9)
(6.5)
(4.3)
3
1
2
(7.1)
(2.4)
(4.8)
(7.5)
(7.5)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
651
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
1
0
1
(%)
(2.5)
(0.0)
(2.5)
Eczema eyelids
Overall
MK+P+R
1
1
(2.5)
(2.5)
0
0
Eye irritation
Overall
MK+P+R
0
0
(0.0)
(0.0)
Eye pain
Overall
P+R
0
0
Eye pruritus
Overall
0
Dry eye
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
4
4
0
(%)
(9.8)
(9.8)
(0.0)
n
1
0
1
(%)
(2.2)
(0.0)
(2.2)
n
2
1
1
(%)
(4.8)
(2.4)
(2.4)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
652
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Ocular hyperaemia
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Photophobia
Overall
P+R
0
0
(0.0)
(0.0)
Presbyopia
Overall
P+R
0
0
Vision blurred
Overall
P+R
0
0
Eye pruritus
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.9)
(4.9)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
653
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Visual acuity reduced
Visual impairment
Vitreous floaters
Xerophthalmia
Gastrointestinal disorders
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
1
(2.4)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
2
1
1
(%)
(5.0)
(2.5)
(2.5)
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Overall
MK+P+R
0
0
(0.0)
(0.0)
Overall
P+R
0
0
Overall
30
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
1
1
0
(%)
(2.2)
(2.2)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(75.0)
33
(78.6)
28
(68.3)
37
(80.4)
20
(47.6)
2.7.4
臨床的安全性
-
654
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
10
(23.8)
12
(28.6)
23
(54.8)
Relationship
MK
P+R
MK+P+R
n
14
8
21
(%)
(35.0)
(20.0)
(52.5)
Abdominal discomfort
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Abdominal distension
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Overall
MK
P+R
3
2
0
(7.5)
(5.0)
(0.0)
Gastrointestinal disorders
Abdominal pain
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
11
11
18
(%)
(26.8)
(26.8)
(43.9)
n
12
8
32
(%)
(26.1)
(17.4)
(69.6)
n
3
8
12
(%)
(7.1)
(19.0)
(28.6)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
2
1
(4.9)
(4.9)
(2.4)
1
1
0
(2.2)
(2.2)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
3
0
0
(7.1)
(0.0)
(0.0)
3
1
0
(7.3)
(2.4)
(0.0)
4
1
1
(8.7)
(2.2)
(2.2)
2
0
2
(4.8)
(0.0)
(4.8)
2.7.4
臨床的安全性
-
655
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
Relationship
MK+P+R
n
1
(%)
(2.5)
Abdominal pain lower
Overall
MK
P+R
MK+P+R
1
1
0
0
(2.5)
(2.5)
(0.0)
(0.0)
1
0
1
0
Abdominal pain upper
Overall
MK
P+R
MK+P+R
4
3
0
1
(10.0)
(7.5)
(0.0)
(2.5)
Abnormal faeces
Overall
MK+P+R
0
0
(0.0)
(0.0)
Abdominal pain
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
(%)
(4.9)
n
2
(%)
(4.3)
n
0
(%)
(0.0)
(2.4)
(0.0)
(2.4)
(0.0)
1
1
0
0
(2.4)
(2.4)
(0.0)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
0
0
1
(2.4)
(0.0)
(0.0)
(2.4)
6
2
1
3
(14.3)
(4.8)
(2.4)
(7.1)
2
0
0
2
(4.9)
(0.0)
(0.0)
(4.9)
4
2
0
2
(8.7)
(4.3)
(0.0)
(4.3)
2
0
0
2
(4.8)
(0.0)
(0.0)
(4.8)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
656
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
2
(4.8)
2
(4.8)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
2
1
1
(%)
(5.0)
(2.5)
(2.5)
Chapped lips
Overall
P+R
1
1
(2.5)
(2.5)
0
0
Cheilitis
Overall
P+R
0
0
(0.0)
(0.0)
Overall
MK
P+R
MK+P+R
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
Aphthous stomatitis
Constipation
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
0
(%)
(2.4)
(2.4)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
2
1
1
(%)
(4.8)
(2.4)
(2.4)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
2
1
1
1
(4.3)
(2.2)
(2.2)
(2.2)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
657
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Diarrhoea
Overall
MK
P+R
MK+P+R
16
5
3
10
(40.0)
(12.5)
(7.5)
(25.0)
17
5
3
11
Dry mouth
Overall
P+R
MK+P+R
3
2
1
(7.5)
(5.0)
(2.5)
Dyspepsia
Overall
MK
12
2
(30.0)
(5.0)
Crohn's disease
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(40.5)
(11.9)
(7.1)
(26.2)
10
2
4
6
(24.4)
(4.9)
(9.8)
(14.6)
22
5
3
18
(47.8)
(10.9)
(6.5)
(39.1)
4
2
2
0
(9.5)
(4.8)
(4.8)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(4.9)
(2.4)
(2.4)
1
0
1
(2.2)
(0.0)
(2.2)
1
0
1
(2.4)
(0.0)
(2.4)
8
2
(19.0)
(4.8)
8
5
(19.5)
(12.2)
6
2
(13.0)
(4.3)
5
1
(11.9)
(2.4)
2.7.4
臨床的安全性
-
658
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
5
(11.9)
Relationship
P+R
MK+P+R
n
3
8
(%)
(7.5)
(20.0)
Dysphagia
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
0
0
0
Epigastric discomfort
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Eructation
Overall
MK+P+R
1
1
(2.5)
(2.5)
Dyspepsia
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
3
(%)
(0.0)
(7.3)
n
1
3
(%)
(2.2)
(6.5)
n
0
4
(%)
(0.0)
(9.5)
(0.0)
(0.0)
(0.0)
2
1
1
(4.9)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
659
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Faeces discoloured
Flatulence
Frequent bowel
movements
Gastrointestinal
disorder
Gastrointestinal pain
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
MK
MK+P+R
n
1
1
0
(%)
(2.5)
(2.5)
(0.0)
Overall
MK+P+R
1
1
(2.5)
(2.5)
0
0
Overall
1
(2.5)
MK+P+R
1
Overall
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
1
0
1
(%)
(2.4)
(0.0)
(2.4)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
(2.5)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
MK+P+R
2
(5.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
Overall
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
660
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Gastrointestinal pain
Gastrooesophageal
reflux disease
Gingival bleeding
Gingival pain
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
6
(15.0)
2
MK
P+R
MK+P+R
2
0
4
(5.0)
(0.0)
(10.0)
Overall
P+R
MK+P+R
0
0
0
Overall
P+R
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(4.8)
2
(4.9)
3
(6.5)
1
(2.4)
0
0
2
(0.0)
(0.0)
(4.8)
0
1
1
(0.0)
(2.4)
(2.4)
0
0
3
(0.0)
(0.0)
(6.5)
0
0
1
(0.0)
(0.0)
(2.4)
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(4.3)
(2.2)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.9)
(4.9)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
661
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
0
(0.0)
1
(2.4)
Relationship
Overall
MK
P+R
n
1
0
1
(%)
(2.5)
(0.0)
(2.5)
Glossitis
Overall
MK
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
Glossodynia
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Overall
MK
1
1
(2.5)
(2.5)
Gingivitis
Haemorrhoids
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
0
(%)
(2.4)
(2.4)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
(2.4)
(0.0)
0
0
(0.0)
(0.0)
1
0
(2.2)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
662
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
MK+P+R
n
0
(%)
(0.0)
Infrequent bowel
movements
Overall
0
(0.0)
0
P+R
0
(0.0)
Lip dry
Overall
P+R
0
0
Overall
P+R
MK+P+R
Overall
MK
Haemorrhoids
Mouth ulceration
Nausea
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
1
0
1
(2.5)
(0.0)
(2.5)
1
0
1
(2.4)
(0.0)
(2.4)
1
0
1
(2.4)
(0.0)
(2.4)
3
1
2
(6.5)
(2.2)
(4.3)
3
2
1
(7.1)
(4.8)
(2.4)
18
4
(45.0)
(10.0)
16
2
(38.1)
(4.8)
13
2
(31.7)
(4.9)
28
6
(60.9)
(13.0)
6
0
(14.3)
(0.0)
2.7.4
臨床的安全性
-
663
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
2
(4.8)
12
(28.6)
Relationship
P+R
MK+P+R
n
2
12
(%)
(5.0)
(30.0)
Overall
MK
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
Oral disorder
Overall
P+R
0
0
(0.0)
(0.0)
Oral mucosal blistering
Overall
P+R
1
1
Retching
Overall
0
Nausea
Oesophageal pain
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
10
(%)
(4.9)
(24.4)
n
2
23
(%)
(4.3)
(50.0)
n
2
4
(%)
(4.8)
(9.5)
(0.0)
(0.0)
(0.0)
2
2
0
(4.9)
(4.9)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
664
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Stomatitis
Overall
P+R
0
0
(0.0)
(0.0)
1
1
Tongue ulceration
Overall
P+R
0
0
(0.0)
(0.0)
Overall
MK+P+R
0
0
Overall
P+R
0
0
Retching
Tooth disorder
Toothache
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(2.4)
(2.4)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
665
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Vomiting
General disorders and
administration site
conditions
Asthenia
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
10
(23.8)
6
(14.3)
5
(11.9)
Relationship
Overall
MK
MK+P+R
n
10
4
6
(%)
(25.0)
(10.0)
(15.0)
Overall
32
(80.0)
30
MK
P+R
MK+P+R
1
24
14
(2.5)
(60.0)
(35.0)
Overall
P+R
MK+P+R
8
3
5
(20.0)
(7.5)
(12.5)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
2
1
(%)
(4.9)
(4.9)
(2.4)
n
13
5
10
(%)
(28.3)
(10.9)
(21.7)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(71.4)
32
(78.0)
30
(65.2)
30
(71.4)
1
25
11
(2.4)
(59.5)
(26.2)
0
25
11
(0.0)
(61.0)
(26.8)
1
27
12
(2.2)
(58.7)
(26.1)
0
27
7
(0.0)
(64.3)
(16.7)
11
7
4
(26.2)
(16.7)
(9.5)
9
4
5
(22.0)
(9.8)
(12.2)
10
5
5
(21.7)
(10.9)
(10.9)
10
6
4
(23.8)
(14.3)
(9.5)
2.7.4
臨床的安全性
-
666
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
Chest pain
Overall
MK
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
1
1
0
Chills
Overall
P+R
MK+P+R
2
2
0
(5.0)
(5.0)
(0.0)
Early satiety
Overall
MK+P+R
0
0
(0.0)
(0.0)
Chest discomfort
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
2
1
1
(%)
(4.3)
(2.2)
(2.2)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
4
2
2
(9.5)
(4.8)
(4.8)
4
4
0
(9.8)
(9.8)
(0.0)
1
1
0
(2.2)
(2.2)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
667
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Face oedema
Fatigue
Feeling abnormal
Feeling hot
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
P+R
MK+P+R
17
11
7
(42.5)
(27.5)
(17.5)
14
7
7
Overall
P+R
0
0
(0.0)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(33.3)
(16.7)
(16.7)
17
13
5
(41.5)
(31.7)
(12.2)
13
8
5
(28.3)
(17.4)
(10.9)
10
8
2
(23.8)
(19.0)
(4.8)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.9)
(4.9)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
668
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
Overall
n
0
(%)
(0.0)
MK+P+R
0
(0.0)
1
Influenza like illness
Overall
P+R
MK+P+R
8
7
1
(20.0)
(17.5)
(2.5)
Injection site erythema
Overall
P+R
MK+P+R
2
1
1
Overall
P+R
General physical health
deterioration
Injection site
inflammation
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(2.4)
0
(0.0)
1
(2.2)
0
(0.0)
9
8
1
(21.4)
(19.0)
(2.4)
14
11
3
(34.1)
(26.8)
(7.3)
9
9
0
(19.6)
(19.6)
(0.0)
8
8
0
(19.0)
(19.0)
(0.0)
(5.0)
(2.5)
(2.5)
2
2
0
(4.8)
(4.8)
(0.0)
2
2
0
(4.9)
(4.9)
(0.0)
1
1
0
(2.2)
(2.2)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
2
(4.9)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.9)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
669
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Injection site pruritus
Injection site reaction
Irritability
Mucosal dryness
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
2
1
1
(%)
(5.0)
(2.5)
(2.5)
Overall
P+R
0
0
(0.0)
(0.0)
1
1
Overall
P+R
MK+P+R
3
2
1
(7.5)
(5.0)
(2.5)
Overall
MK
P+R
3
1
1
(7.5)
(2.5)
(2.5)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
(2.4)
(2.4)
1
1
(2.4)
(2.4)
1
1
(2.2)
(2.2)
1
1
(2.4)
(2.4)
4
3
1
(9.5)
(7.1)
(2.4)
4
4
0
(9.8)
(9.8)
(0.0)
5
5
0
(10.9)
(10.9)
(0.0)
7
6
1
(16.7)
(14.3)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
670
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Mucosal dryness
Mucosal inflammation
Oedema peripheral
Pain
Pyrexia
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
1
(%)
(2.5)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
Overall
MK
0
0
(0.0)
(0.0)
Overall
P+R
MK+P+R
0
0
0
Overall
4
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
1
(2.4)
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
2
1
1
(4.9)
(2.4)
(2.4)
2
2
0
(4.3)
(4.3)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
(10.0)
7
(16.7)
4
(9.8)
8
(17.4)
10
(23.8)
2.7.4
臨床的安全性
-
671
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
6
(14.3)
1
(2.4)
Relationship
P+R
MK+P+R
n
4
0
(%)
(10.0)
(0.0)
Overall
0
(0.0)
1
P+R
0
(0.0)
Overall
MK+P+R
1
1
Immune system disorders
Overall
MK
MK+P+R
Anaphylactic reaction
Overall
Pyrexia
Sensation of foreign
body
Thirst
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
3
1
(%)
(7.3)
(2.4)
n
7
1
(%)
(15.2)
(2.2)
n
10
0
(%)
(23.8)
(0.0)
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
0
(2.5)
(2.5)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
672
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Drug hypersensitivity
Overall
MK
1
1
(2.5)
(2.5)
0
0
Infections and infestations
Overall
MK
P+R
MK+P+R
4
0
2
3
(10.0)
(0.0)
(5.0)
(7.5)
Bronchitis
Overall
P+R
0
0
Candidiasis
Overall
0
Anaphylactic reaction
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
4
0
4
0
(9.5)
(0.0)
(9.5)
(0.0)
6
1
4
2
(14.6)
(2.4)
(9.8)
(4.9)
7
0
5
2
(15.2)
(0.0)
(10.9)
(4.3)
3
0
3
1
(7.1)
(0.0)
(7.1)
(2.4)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
673
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
P+R
n
0
(%)
(0.0)
Cystitis
Overall
P+R
0
0
(0.0)
(0.0)
1
1
Ear infection
Overall
P+R
0
0
(0.0)
(0.0)
Gastroenteritis
Overall
MK
P+R
0
0
0
Overall
MK+P+R
0
0
Candidiasis
Herpes ophthalmic
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
674
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
1
1
(%)
(2.5)
(2.5)
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Overall
MK+P+R
1
1
(2.5)
(2.5)
Localised infection
Overall
P+R
1
1
Oral fungal infection
Overall
P+R
1
0
Herpes simplex
Herpes zoster
Hordeolum
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(2.5)
(0.0)
0
0
(0.0)
(0.0)
2
1
(4.9)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
675
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
1
(%)
(2.5)
Overall
P+R
MK+P+R
1
1
1
(2.5)
(2.5)
(2.5)
0
0
0
Otitis externa
Overall
P+R
0
0
(0.0)
(0.0)
Otitis media
Overall
P+R
1
1
Overall
MK+P+R
0
0
Oral fungal infection
Oral herpes
Pertussis
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
2
2
0
(4.3)
(4.3)
(0.0)
2
2
0
(4.8)
(4.8)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
676
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
0
(0.0)
1
P+R
MK+P+R
0
0
(0.0)
(0.0)
Urinary tract infection
Overall
P+R
0
0
Urinary tract infection
bacterial
Overall
MK+P+R
Pharyngitis
Upper respiratory tract
infection
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
1
1
(%)
(2.4)
(2.4)
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
1
0
(2.4)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
1
(0.0)
(2.4)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
677
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Vulvovaginal candidiasis
Vulvovaginal mycotic
infection
Injury, poisoning and
procedural complications
Burn oesophageal
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
1
1
(%)
(2.5)
(2.5)
Overall
0
(0.0)
0
MK+P+R
0
(0.0)
Overall
1
MK+P+R
Overall
MK+P+R
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
(2.5)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
1
(2.5)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
678
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Contusion
Thermal burn
Investigations
Alanine
aminotransferase
increased
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
1
1
(%)
(2.5)
(2.5)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Overall
MK
P+R
MK+P+R
2
0
1
1
(5.0)
(0.0)
(2.5)
(2.5)
Overall
0
MK+P+R
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
5
0
5
0
(11.9)
(0.0)
(11.9)
(0.0)
6
0
3
4
(14.6)
(0.0)
(7.3)
(9.8)
7
1
2
4
(15.2)
(2.2)
(4.3)
(8.7)
3
0
1
2
(7.1)
(0.0)
(2.4)
(4.8)
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
2.7.4
臨床的安全性
-
679
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
MK+P+R
0
(0.0)
0
Overall
0
(0.0)
MK+P+R
0
Blood creatinine
increased
Overall
Blood lactate
dehydrogenase
increased
Aspartate
aminotransferase
increased
Blood creatine
phosphokinase
increased
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
1
(%)
(2.4)
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
MK
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
Overall
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
MK+P+R
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
680
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
MK+P+R
0
(0.0)
0
Blood thyroid
stimulating hormone
increased
Overall
0
(0.0)
P+R
0
Electrocardiogram QT
prolonged
Overall
Blood thyroid
stimulating hormone
decreased
Electrocardiogram T
wave amplitude
increased
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
MK+P+R
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
Overall
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
681
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Haemoglobin decreased
Overall
P+R
0
0
(0.0)
(0.0)
Neutrophil count
decreased
Overall
0
P+R
Platelet count decreased
Overall
P+R
Electrocardiogram T
wave amplitude
increased
Gastric pH decreased
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
2
(4.8)
(4.8)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
2
(4.8)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.8)
1
(2.4)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
682
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
2
1
1
(%)
(5.0)
(2.5)
(2.5)
White blood cell count
decreased
Overall
0
(0.0)
0
P+R
0
(0.0)
Metabolism and nutrition
disorders
Overall
7
MK
P+R
MK+P+R
0
2
6
Weight decreased
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
4
1
3
(%)
(9.8)
(2.4)
(7.3)
n
3
0
3
(%)
(6.5)
(0.0)
(6.5)
n
1
0
1
(%)
(2.4)
(0.0)
(2.4)
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
(17.5)
14
(33.3)
7
(17.1)
7
(15.2)
3
(7.1)
(0.0)
(5.0)
(15.0)
0
8
6
(0.0)
(19.0)
(14.3)
1
2
5
(2.4)
(4.9)
(12.2)
1
4
2
(2.2)
(8.7)
(4.3)
0
3
0
(0.0)
(7.1)
(0.0)
2.7.4
臨床的安全性
-
683
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
13
(31.0)
8
(19.0)
5
(11.9)
Relationship
Overall
P+R
MK+P+R
n
7
2
6
(%)
(17.5)
(5.0)
(15.0)
Dehydration
Overall
MK
0
0
(0.0)
(0.0)
0
0
Diabetes mellitus
Overall
P+R
0
0
(0.0)
(0.0)
Fat intolerance
Overall
MK
0
0
Hypokalaemia
Overall
0
Decreased appetite
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
7
2
5
(%)
(17.1)
(4.9)
(12.2)
n
5
3
2
(%)
(10.9)
(6.5)
(4.3)
n
3
3
0
(%)
(7.1)
(7.1)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
684
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Hypokalaemia
Musculoskeletal and
connective tissue disorders
Amyotrophy
Arthralgia
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
12
(30.0)
15
MK
P+R
MK+P+R
0
4
8
(0.0)
(10.0)
(20.0)
Overall
P+R
0
0
Overall
P+R
MK+P+R
6
3
3
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(35.7)
16
(39.0)
19
(41.3)
16
(38.1)
0
11
4
(0.0)
(26.2)
(9.5)
0
10
6
(0.0)
(24.4)
(14.6)
1
15
6
(2.2)
(32.6)
(13.0)
0
11
6
(0.0)
(26.2)
(14.3)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(15.0)
(7.5)
(7.5)
4
4
0
(9.5)
(9.5)
(0.0)
3
3
0
(7.3)
(7.3)
(0.0)
7
6
1
(15.2)
(13.0)
(2.2)
3
3
0
(7.1)
(7.1)
(0.0)
2.7.4
臨床的安全性
-
685
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
MK
P+R
MK+P+R
n
3
0
0
3
(%)
(7.5)
(0.0)
(0.0)
(7.5)
Muscle fatigue
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Muscle spasms
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Overall
P+R
0
0
(0.0)
(0.0)
Back pain
Muscular weakness
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
0
1
1
(%)
(4.9)
(0.0)
(2.4)
(2.4)
n
4
1
3
1
(%)
(8.7)
(2.2)
(6.5)
(2.2)
n
1
0
1
1
(%)
(2.4)
(0.0)
(2.4)
(2.4)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2
2
0
(4.8)
(4.8)
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
1
(2.2)
(2.2)
(2.2)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
(2.4)
(2.4)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
686
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
Overall
n
0
(%)
(0.0)
P+R
0
(0.0)
0
Musculoskeletal pain
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Musculoskeletal stiffness
Overall
MK+P+R
0
0
Myalgia
Overall
P+R
MK+P+R
3
1
2
Musculoskeletal chest
pain
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
5
5
0
(10.9)
(10.9)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(7.5)
(2.5)
(5.0)
4
3
1
(9.5)
(7.1)
(2.4)
12
9
3
(29.3)
(22.0)
(7.3)
11
7
4
(23.9)
(15.2)
(8.7)
8
4
4
(19.0)
(9.5)
(9.5)
2.7.4
臨床的安全性
-
687
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Neck pain
Overall
P+R
MK+P+R
1
1
0
(2.5)
(2.5)
(0.0)
2
1
1
Pain in extremity
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
Myositis
Synovial cyst
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(4.8)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
0
(2.2)
(2.2)
(0.0)
2
2
0
(4.8)
(4.8)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
688
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
16
(38.1)
3
(7.1)
6
(14.3)
8
(19.0)
Relationship
Overall
MK
P+R
MK+P+R
n
18
2
6
13
(%)
(45.0)
(5.0)
(15.0)
(32.5)
Ageusia
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Amnesia
Overall
P+R
0
0
(0.0)
(0.0)
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Nervous system disorders
Disturbance in attention
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
25
4
13
15
(%)
(61.0)
(9.8)
(31.7)
(36.6)
n
18
0
13
9
(%)
(39.1)
(0.0)
(28.3)
(19.6)
n
13
0
8
7
(%)
(31.0)
(0.0)
(19.0)
(16.7)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
3
3
0
(6.5)
(6.5)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
2.7.4
臨床的安全性
-
689
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
2
(4.8)
1
(2.4)
Relationship
Overall
P+R
MK+P+R
n
3
1
2
(%)
(7.5)
(2.5)
(5.0)
Dizziness postural
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Dysgeusia
Overall
MK
MK+P+R
4
1
3
(10.0)
(2.5)
(7.5)
Headache
Overall
MK
P+R
15
1
6
(37.5)
(2.5)
(15.0)
Dizziness
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
4
2
2
(%)
(9.8)
(4.9)
(4.9)
n
4
2
2
(%)
(8.7)
(4.3)
(4.3)
n
4
2
2
(%)
(9.5)
(4.8)
(4.8)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
3
2
1
(7.1)
(4.8)
(2.4)
4
2
2
(9.8)
(4.9)
(4.9)
1
0
1
(2.2)
(0.0)
(2.2)
1
0
1
(2.4)
(0.0)
(2.4)
9
0
4
(21.4)
(0.0)
(9.5)
18
2
6
(43.9)
(4.9)
(14.6)
14
0
8
(30.4)
(0.0)
(17.4)
9
0
6
(21.4)
(0.0)
(14.3)
2.7.4
臨床的安全性
-
690
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
Relationship
MK+P+R
n
8
(%)
(20.0)
Hyperaesthesia
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Hypoaesthesia
Overall
MK+P+R
0
0
(0.0)
(0.0)
Lethargy
Overall
P+R
0
0
Memory impairment
Overall
P+R
0
0
Headache
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
10
(%)
(24.4)
n
7
(%)
(15.2)
n
3
(%)
(7.1)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
691
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Paraesthesia
Overall
P+R
MK+P+R
2
0
2
(5.0)
(0.0)
(5.0)
0
0
0
Parosmia
Overall
MK+P+R
0
0
(0.0)
(0.0)
Presyncope
Overall
MK
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Neuralgia
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
1
1
(%)
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
3
2
1
(7.3)
(4.9)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
692
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Restless legs syndrome
Sciatica
Somnolence
Syncope
Psychiatric disorders
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
1
1
(%)
(2.5)
(2.5)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Overall
P+R
0
0
(0.0)
(0.0)
Overall
MK+P+R
0
0
Overall
MK
18
1
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(45.0)
(2.5)
19
0
(45.2)
(0.0)
21
0
(51.2)
(0.0)
24
0
(52.2)
(0.0)
16
0
(38.1)
(0.0)
2.7.4
臨床的安全性
-
693
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
15
(35.7)
5
(11.9)
Relationship
P+R
MK+P+R
n
12
7
(%)
(30.0)
(17.5)
Abnormal dreams
Overall
MK
MK+P+R
1
1
0
(2.5)
(2.5)
(0.0)
0
0
0
Affect lability
Overall
MK+P+R
1
1
(2.5)
(2.5)
Affective disorder
Overall
P+R
0
0
Aggression
Overall
0
Psychiatric disorders
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
15
10
(%)
(36.6)
(24.4)
n
16
10
(%)
(34.8)
(21.7)
n
13
3
(%)
(31.0)
(7.1)
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
2
(4.8)
2.7.4
臨床的安全性
-
694
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
P+R
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Anxiety
Overall
P+R
MK+P+R
4
3
1
(10.0)
(7.5)
(2.5)
2
2
0
Apathy
Overall
MK+P+R
0
0
(0.0)
(0.0)
Completed suicide
Overall
P+R
1
1
Depressed mood
Overall
1
Aggression
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
1
(%)
(0.0)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
2
0
(%)
(4.8)
(0.0)
(4.8)
(4.8)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
2
1
1
(4.3)
(2.2)
(2.2)
1
1
0
(2.4)
(2.4)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(2.5)
3
(7.1)
5
(12.2)
2
(4.3)
3
(7.1)
2.7.4
臨床的安全性
-
695
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Depressed mood
Depression
Emotional disorder
Insomnia
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
0
(0.0)
Relationship
P+R
MK+P+R
n
0
1
(%)
(0.0)
(2.5)
Overall
P+R
MK+P+R
3
3
0
(7.5)
(7.5)
(0.0)
6
6
0
Overall
P+R
0
0
(0.0)
(0.0)
Overall
P+R
MK+P+R
7
6
1
(17.5)
(15.0)
(2.5)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
3
2
(%)
(7.3)
(4.9)
n
2
0
(%)
(4.3)
(0.0)
n
2
1
(%)
(4.8)
(2.4)
(14.3)
(14.3)
(0.0)
7
7
0
(17.1)
(17.1)
(0.0)
8
4
4
(17.4)
(8.7)
(8.7)
1
1
0
(2.4)
(2.4)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
6
5
1
(14.3)
(11.9)
(2.4)
12
8
5
(29.3)
(19.5)
(12.2)
6
6
1
(13.0)
(13.0)
(2.2)
9
8
1
(21.4)
(19.0)
(2.4)
2.7.4
臨床的安全性
-
696
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
1
(2.4)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Major depression
Overall
P+R
1
1
(2.5)
(2.5)
Mood altered
Overall
P+R
0
0
Mood swings
Overall
P+R
2
2
Libido decreased
Loss of libido
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(5.0)
(5.0)
2
2
(4.8)
(4.8)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
697
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Panic attack
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Sleep disorder
Overall
P+R
MK+P+R
5
1
4
(12.5)
(2.5)
(10.0)
Overall
P+R
1
1
Overall
2
Nervousness
Suicidal ideation
Renal and urinary disorders
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
2
(%)
(4.9)
(4.9)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
5
2
3
(11.9)
(4.8)
(7.1)
4
0
4
(9.8)
(0.0)
(9.8)
8
3
5
(17.4)
(6.5)
(10.9)
4
3
1
(9.5)
(7.1)
(2.4)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(5.0)
1
(2.4)
1
(2.4)
1
(2.2)
2
(4.8)
2.7.4
臨床的安全性
-
698
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
MK+P+R
n
2
(%)
(5.0)
Chromaturia
Overall
MK+P+R
0
0
(0.0)
(0.0)
1
1
Dysuria
Overall
MK+P+R
1
1
(2.5)
(2.5)
Micturition urgency
Overall
MK+P+R
1
1
Pollakiuria
Overall
MK+P+R
0
0
Renal and urinary disorders
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
1
(%)
(2.2)
n
2
(%)
(4.8)
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(2.5)
(2.5)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
699
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Polyuria
Urethral pain
Reproductive system and
breast disorders
Erectile dysfunction
Vulvovaginal pruritus
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Overall
0
(0.0)
MK+P+R
0
Overall
MK+P+R
Overall
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
2
(4.3)
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
2
(4.3)
0
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
700
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Vulvovaginal pruritus
Respiratory, thoracic and
mediastinal disorders
Cough
Dry throat
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
7
(17.5)
17
MK
P+R
MK+P+R
1
1
6
(2.5)
(2.5)
(15.0)
Overall
P+R
MK+P+R
4
1
3
Overall
MK
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(40.5)
14
(34.1)
17
(37.0)
11
(26.2)
0
8
10
(0.0)
(19.0)
(23.8)
1
10
5
(2.4)
(24.4)
(12.2)
0
10
9
(0.0)
(21.7)
(19.6)
0
8
4
(0.0)
(19.0)
(9.5)
(10.0)
(2.5)
(7.5)
11
6
5
(26.2)
(14.3)
(11.9)
4
2
2
(9.8)
(4.9)
(4.9)
11
6
5
(23.9)
(13.0)
(10.9)
7
5
2
(16.7)
(11.9)
(4.8)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2
0
(4.3)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
701
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
P+R
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Dysphonia
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Dyspnoea
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Dyspnoea exertional
Overall
P+R
MK+P+R
2
0
2
(5.0)
(0.0)
(5.0)
Dry throat
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
1
1
(%)
(2.2)
(2.2)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
5
3
2
(11.9)
(7.1)
(4.8)
6
5
1
(14.6)
(12.2)
(2.4)
7
3
4
(15.2)
(6.5)
(8.7)
4
3
1
(9.5)
(7.1)
(2.4)
3
0
3
(7.1)
(0.0)
(7.1)
1
1
0
(2.4)
(2.4)
(0.0)
3
1
2
(6.5)
(2.2)
(4.3)
0
0
0
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
702
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
MK+P+R
n
0
0
0
(%)
(0.0)
(0.0)
(0.0)
Overall
P+R
0
0
(0.0)
(0.0)
1
1
Nasal congestion
Overall
MK+P+R
0
0
(0.0)
(0.0)
Nasal dryness
Overall
P+R
MK+P+R
1
0
1
(2.5)
(0.0)
(2.5)
Epistaxis
Haemoptysis
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
2
1
1
(%)
(4.9)
(2.4)
(2.4)
n
2
1
1
(%)
(4.3)
(2.2)
(2.2)
n
1
0
1
(%)
(2.4)
(0.0)
(2.4)
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
703
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Oropharyngeal pain
Overall
MK
P+R
MK+P+R
1
0
0
1
(2.5)
(0.0)
(0.0)
(2.5)
0
0
0
0
Painful respiration
Overall
MK+P+R
1
1
(2.5)
(2.5)
Overall
P+R
0
0
(0.0)
(0.0)
Nocturnal dyspnoea
Rhinitis allergic
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
2
1
1
0
(4.9)
(2.4)
(2.4)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
704
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Throat irritation
Overall
P+R
0
0
(0.0)
(0.0)
0
0
Upper respiratory tract
congestion
Overall
1
(2.5)
MK
1
Wheezing
Overall
P+R
Yawning
Overall
Rhinorrhoea
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
(2.5)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
705
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Yawning
Skin and subcutaneous
tissue disorders
Alopecia
Blister
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
P+R
n
0
(%)
(0.0)
Overall
20
(50.0)
24
MK
P+R
MK+P+R
3
7
13
(7.5)
(17.5)
(32.5)
Overall
P+R
MK+P+R
4
2
2
Overall
P+R
0
0
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
(%)
(2.4)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(57.1)
25
(61.0)
29
(63.0)
19
(45.2)
0
13
16
(0.0)
(31.0)
(38.1)
1
16
12
(2.4)
(39.0)
(29.3)
2
13
21
(4.3)
(28.3)
(45.7)
2
14
9
(4.8)
(33.3)
(21.4)
(10.0)
(5.0)
(5.0)
4
4
0
(9.5)
(9.5)
(0.0)
7
5
2
(17.1)
(12.2)
(4.9)
8
6
2
(17.4)
(13.0)
(4.3)
3
3
0
(7.1)
(7.1)
(0.0)
(0.0)
(0.0)
2
1
(4.8)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
706
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
1
(2.4)
Relationship
MK+P+R
n
0
(%)
(0.0)
Overall
P+R
MK+P+R
2
0
2
(5.0)
(0.0)
(5.0)
1
0
1
Dermatitis allergic
Overall
MK
1
1
(2.5)
(2.5)
Dermatomyositis
Overall
MK+P+R
0
0
Overall
P+R
0
0
Blister
Dermatitis
Drug eruption
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
0
(%)
(0.0)
n
0
(%)
(0.0)
(2.4)
(0.0)
(2.4)
3
2
1
(7.3)
(4.9)
(2.4)
2
1
1
(4.3)
(2.2)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
707
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
3
(7.1)
1
(2.4)
2
(4.8)
Relationship
Overall
P+R
MK+P+R
n
6
3
3
(%)
(15.0)
(7.5)
(7.5)
Eczema
Overall
MK
P+R
MK+P+R
1
0
0
1
(2.5)
(0.0)
(0.0)
(2.5)
3
0
1
2
Hyperhidrosis
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Overall
0
(0.0)
Dry skin
Increased tendency to
bruise
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
4
1
3
(%)
(9.8)
(2.4)
(7.3)
n
7
5
2
(%)
(15.2)
(10.9)
(4.3)
n
6
6
0
(%)
(14.3)
(14.3)
(0.0)
(7.1)
(0.0)
(2.4)
(4.8)
4
1
1
2
(9.8)
(2.4)
(2.4)
(4.9)
2
0
1
1
(4.3)
(0.0)
(2.2)
(2.2)
4
0
3
1
(9.5)
(0.0)
(7.1)
(2.4)
2
2
0
(4.8)
(4.8)
(0.0)
2
1
1
(4.9)
(2.4)
(2.4)
1
1
0
(2.2)
(2.2)
(0.0)
1
1
0
(2.4)
(2.4)
(0.0)
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
2.7.4
臨床的安全性
-
708
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
P+R
n
0
(%)
(0.0)
Nail discolouration
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Nail disorder
Overall
MK+P+R
0
0
(0.0)
(0.0)
Night sweats
Overall
P+R
MK+P+R
0
0
0
Onychoclasis
Overall
P+R
0
0
Increased tendency to
bruise
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(4.9)
(2.4)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
2
1
(4.3)
(2.2)
0
0
(0.0)
(0.0)
2.7.4
臨床的安全性
-
709
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
MK+P+R
n
0
(%)
(0.0)
Pain of skin
Overall
MK
0
0
(0.0)
(0.0)
0
0
Papule
Overall
P+R
1
1
(2.5)
(2.5)
Overall
MK+P+R
0
0
Overall
MK
P+R
13
1
5
Onychoclasis
Photosensitivity reaction
Pruritus
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
1
(%)
(2.2)
n
0
(%)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
2
2
(4.8)
(4.8)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(32.5)
(2.5)
(12.5)
11
0
6
(26.2)
(0.0)
(14.3)
10
0
8
(24.4)
(0.0)
(19.5)
13
0
4
(28.3)
(0.0)
(8.7)
9
1
6
(21.4)
(2.4)
(14.3)
2.7.4
臨床的安全性
-
710
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
5
(11.9)
Relationship
MK+P+R
n
7
(%)
(17.5)
Pruritus generalised
Overall
P+R
MK+P+R
1
1
0
(2.5)
(2.5)
(0.0)
2
1
1
Purpura
Overall
MK+P+R
0
0
(0.0)
(0.0)
Rash
Overall
P+R
MK+P+R
6
2
4
Overall
0
Pruritus
Rash erythematous
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
3
(%)
(7.3)
n
10
(%)
(21.7)
n
2
(%)
(4.8)
(4.8)
(2.4)
(2.4)
1
1
0
(2.4)
(2.4)
(0.0)
1
0
1
(2.2)
(0.0)
(2.2)
2
2
0
(4.8)
(4.8)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.2)
(2.2)
0
0
(0.0)
(0.0)
(15.0)
(5.0)
(10.0)
6
4
3
(14.3)
(9.5)
(7.1)
6
4
2
(14.6)
(9.8)
(4.9)
12
1
11
(26.1)
(2.2)
(23.9)
7
2
5
(16.7)
(4.8)
(11.9)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(4.8)
2.7.4
臨床的安全性
-
711
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
P+R
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Rash papular
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
Rash pruritic
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Seborrhoeic dermatitis
Overall
MK+P+R
0
0
(0.0)
(0.0)
Rash erythematous
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
n
1
1
(%)
(2.4)
(2.4)
(4.8)
(2.4)
(2.4)
1
0
1
(2.4)
(0.0)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
2
1
1
(4.3)
(2.2)
(2.2)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
2.7.4
臨床的安全性
-
712
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
MK
MK+P+R
1
1
0
(2.5)
(2.5)
(0.0)
1
0
1
Skin induration
Overall
P+R
0
0
(0.0)
(0.0)
Trichorrhexis
Overall
P+R
0
0
Urticaria
Overall
0
Skin exfoliation
Skin fissures
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
1
1
(%)
(2.4)
(2.4)
n
0
0
(%)
(0.0)
(0.0)
n
0
0
(%)
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(2.4)
2.7.4
臨床的安全性
-
713
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
Relationship
P+R
n
0
(%)
(0.0)
Urticaria physical
Overall
MK+P+R
0
0
(0.0)
(0.0)
0
0
Xeroderma
Overall
MK
P+R
MK+P+R
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
Urticaria
Vascular disorders
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
(%)
(0.0)
n
0
(%)
(0.0)
n
1
(%)
(2.4)
(0.0)
(0.0)
1
1
(2.4)
(2.4)
0
0
(0.0)
(0.0)
0
0
(0.0)
(0.0)
1
0
0
1
(2.4)
(0.0)
(0.0)
(2.4)
1
0
1
0
(2.4)
(0.0)
(2.4)
(0.0)
2
1
0
1
(4.3)
(2.2)
(0.0)
(2.2)
0
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
1
0
1
(2.4)
(0.0)
(2.4)
1
1
0
(2.4)
(2.4)
(0.0)
4
1
3
(8.7)
(2.2)
(6.5)
0
0
0
(0.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
714
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
Flushing
Hot flush
Orthostatic hypotension
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
0
(0.0)
Relationship
Overall
MK+P+R
n
0
0
(%)
(0.0)
(0.0)
Overall
P+R
MK+P+R
0
0
0
(0.0)
(0.0)
(0.0)
1
0
1
Overall
0
(0.0)
0
2.7.4
715
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
n
0
0
(%)
(0.0)
(0.0)
n
2
2
(%)
(4.3)
(4.3)
n
0
0
(%)
(0.0)
(0.0)
(2.4)
(0.0)
(2.4)
1
1
0
(2.4)
(2.4)
(0.0)
1
1
0
(2.2)
(2.2)
(0.0)
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
臨床的安全性
-
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:34
副作用発現例数（009 試験：非肝硬変患者）（続き）
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV
24-wk MK-7009 600
mg bid + Peg-IFN +
RBV / 24-wk PBO +
Peg-IFN + RBV
n
(%)
0
(0.0)
48-wk MK-7009 300
mg bid + Peg-IFN +
RBV
48-wk MK-7009 600
mg bid + Peg-IFN +
RBV
48-wk PBO +
Peg-IFN + RBV
Relationship
n
(%)
n
(%)
n
(%)
n
(%)
Orthostatic hypotension
MK+P+R
0
(0.0)
0
(0.0)
1
(2.2)
0
(0.0)
Every patient is counted once on each applicable row.
A system organ class or specific adverse event appears on this report only if its incidence in one or more of the columns is greater than or equal to the percent
incidence specified in the report title, after rounding.
Relationship: study medication(s) to which the investigator attributed the adverse event. MK = MK-7009/PLACEBO, P+R = PEG-IFN AND RIBAVIRIN,
MK+P+R = MK-7009/PLACEBO AND PEG-IFN AND RIBAVIRIN.
Relationship P+R signifies the adverse event was attributed to one or more of the following: peg-IFN or ribavirin.
Relationship MK+P+R signifies the adverse event was attributed to one or more of the following: MK-7009/placebo or peg-IFN or ribavirin.
2.7.4
臨床的安全性
-
716
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:35
割付
番号
AST、ALT 及び総ビリルビンの PDLC に該当した患者の一覧（043 試験）
性別
ベース
ライン
12週投与群
14809
男性
28
14821
男性
121
14822
女性
NA
14828
男性
32
14870
女性
20
14938
女性
34
14993†
男性
21
14962
男性
14981
AST
最大値
最終投
与日又
は最終
観察日
ALT
最大値
ベース
ライン
総ビリルビン
最大値
最終投
与日又
は最終
観察日
最終投
与日又
は最終
観察日
ベース
ライン
270
Week 10
200
Week 12
NA
18
Week 24
18
Week 24
NA
NA
NA
NA
0.9
49
Week 24
20
Week 24
29
Week 12
NA
NA
0.6
Week 24
0.9
Week 24
NA
NA
NA
NA
NA
NA
NA
NA
109
Week 3
60
Week 10
46
Week 8
NA
3.4
Week 12
2.1
Week 3
NA
NA
NA
NA
NA
NA
NA
0.5
0.9
Week 24
0.9
Week 24
NA
169
Week 10
189
Week 12
NA
23
Week 24
28
Week 24
NA
NA
50
Week 3
56
Week 10
45
Week 8
44
FU12
NA
38
Week 24
21
Week 24
35
Week 12
23
FU 24
NA
男性
NA
NA
NA
NA
NA
NA
0.4
15045†
女性
35
NA
NA
NA
女性
NA
NA
NA
35
NA
NA
NA
15081†
女性
NA
NA
NA
NA
28
FU 24
20
Week 24
20
FU 24
NA
NA
15077†
45
FU 12
44
Week 16
47
FU 4
NA
NA
女性
39
FU 24
NA
22
15068†
57
FU 12
NA
2.2
Week 1
1.8
Week 1
NA
NA
15085
女性
26
23
NA
53
Week 8
NA
13
Week 24
NA
NA
女性
19
Week 24
NA
0.5
Week 8
NA
15159
56
Week 8
NA
1.3
Week 1
NA
15192
男性
23
NA
NA
152
Week 12
NA
18
Week 24
NA
NA
男性
16
Week 24
NA
0.7
Week 24
NA
15217
58
Week 12
NA
1.3
Week 1
NA
15233
女性
NA
NA
NA
36
NA
女性
48
NA
58
NA
NA
NA
24週投与群
14810
女性
99
Week 8
12
Week 24
NA
1.4
FU 24
NA
15368
46
Week 1
80
Week 8
1.9
Week 2
NA
30
NA
NA
NA
NA
14830†
女性
31
20
Week 24
54
FU 24
12
Week 24
NA
46
153
Week 10
68
Week 24
63
Week 16
NA
女性
28
Week 24
47
FU 24
22
Week 24
25
14814
109
Week 10
59
Week 24
68
Week 16
0.9
2.9
Week 2
0.5
Week 24
2.7.4
36
128
NA
53
20
38
19
NA
34
60
23
臨床的安全性
-
717
-
0.8
0.5
1.6
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:35
割付
番号
AST、ALT 及び総ビリルビンの PDLC に該当した患者の一覧（043 試験）
（続き）
性別
ベース
ライン
AST
最大値
最終投
与日又
は最終
観察日
ベース
ライン
41
Week 7
96
Week 24
NA
19
Week 24
25
FU 24
NA
NA
208
FU 12
56
Week 2
70
Week 20
NA
30
FU 24
37
Week 24
25
Week 24
NA
39
21
Week 24
52
FU 24
(Day
472)
16
Week 24
29
Week 12
(Day
105)
NA
NA
45
ALT
最大値
総ビリルビン
最大値
最終投
与日又
は最終
観察日
最終投
与日又
は最終
観察日
ベース
ライン
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
38
47
Week 8
349
FU 12
53
Week 3
46
Week 20
NA
15
Week 24
21
FU 24
26
Week 24
20
Week 24
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.3
67
Week 16
145
FU 24
NA
0.5
Week 24
NA
NA
NA
NA
NA
17
Week 24
65
FU 24
(Day
472)
NA
1.1
Week 2
NA
NA
NA
NA
68
Week 12
(Day
105)
NA
NA
NA
NA
NA
289
Week 12
(Day
87)
NA
NA
0.7
Week 24
0.6
Week 24
NA
24週投与群
14833
男性
27
14858
男性
86
14860
女性
NA
14867†
女性
35
15001
女性
34
15002
男性
45
15024
男性
NA
15083
男性
29
15122†
女性
35
15123
女性
29
15153
女性
28
15203
男性
NA
51
Week 16
101
FU 24
(Day
344)
50
Week 7
235
Week 12
(Day
87)
NA
15211
男性
NA
NA
NA
NA
NA
NA
0.4
15261
男性
34
57
NA
NA
男性
NA
NA
NA
NA
15313
女性
45
17
Week 8 Week 24
15318†
女性
55
115
35
FU 4
FU 24
15365†
女性
37
56
35
FU 12
FU 24
†
3剤併用投与後、再燃がみられた患者
NA：PDLC に該当せず
39
33
Week 24
55
FU 12
29
FU 24
14
Week 24
44
FU 24
36
FU 24
NA
15309
321
Week 12
127
FU 4
43
FU 12
68
Week 8
104
FU 4
52
FU 12
NA
男性
23
Week 24
44
FU 12
NA
47
15299†
167
Week 12
127
FU 4
NA
1.5
Week 2
1.4
Week 1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
27
36
NA
29
34
92
32
36
2.7.4
85
44
臨床的安全性
-
718
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:36
割付
番号
AST、ALT 及び総ビリルビンの PDLC に該当した患者の一覧（044 試験）
性別
ベース
ライン
AST
最大値
最終投
与日又
は最終
観察日
ALT
最大値
ベース
ライン
最終投
与日又
は最終
観察日
ベース
ライン
12週投与群
15451
男性
NA
NA
NA
NA
NA
NA
0.4
15462
女性
NA
NA
NA
45
男性
59
女性
NA
34
FU 24
NA
NA
15513
63
Week 24
NA
10
Week 24
NA
NA
15466
58
Week 10
NA
NA
NA
NA
0.5
15515†
女性
40
NA
NA
56
Week 12
NA
33
Week 24
NA
NA
男性
34
Week 24
NA
49
15578
46
Week 20
NA
15582†
女性
78
NA
67
89
FU 24
NA
24週投与群
15472
女性
102
FU 24
29
25
44
Week 24
NA
94
Week 5
74
Week 24
94
Week 8
54
24
Week 24
FU 24
15474
男性
157
208
103
Week 12 Week 24
15521
女性
26
68
28
Week 5 Week 24
15577
女性
33
66
29
Week 24
FU 24
15581
男性
27
84
38
Week 8 Week 24
†
3剤併用投与後、再燃がみられた患者
NA：PDLC に該当せず
2.7.4
NA
19
30
35
臨床的安全性
-
719
-
総ビリルビン
最大値
最終投
与日又
は最終
観察日
1.1
Week 4
NA
0.6
Week 24
NA
4.1
Week 1
1.7
Week 2
NA
0.7
FU 24
0.8
Week 20
NA
NA
1.6
Week 2
NA
0.8
Week 24
NA
20
FU 24
NA
NA
NA
NA
0.7
22
Week 24
22
FU 24
62
Week 24
NA
3.1
Week 12
NA
0.8
FU 24
NA
NA
NA
NA
0.4
1.7
Week 4
0.6
Week 24
0.5
NA
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:37
割付
番号
AST、ALT 及び総ビリルビンの PDLC に該当した患者の一覧（045 試験）
性別
ベース
ライン
24週投与群
15375†
男性
59
15377
男性
54
15382†
男性
NA
15387
女性
39
15388
女性
38
15389†
男性
NA
15391
男性
73
15399†
男性
39
15400†
女性
44
15401
男性
83
15402†
男性
42
15405
男性
NA
15407†
男性
AST
最大値
最終投
与日又
は最終
観察日
63
FU 4
58
Week 12
NA
45
FU 24
26
Week 24
NA
46
FU 4
48
Week 20
NA
42
FU 24
37
Week 24
NA
NA
85
Week 16
44
FU 12
289
FU 4
31
Week 24
39
FU 24
187
FU 24
69
190
FU 12
50
FU 24
NA
187
FU 20
NA
107
NA
NA
63
NA
31
31
65
69
38
81
31
134
26
Week 8 Week 24
15408†
男性
31
191
51
Week 7
Week 8
†
3剤併用投与後、再燃がみられた患者
NA：PDLC に該当せず
2.7.4
ALT
最大値
ベース
ライン
33
41
ベース
ライン
76
FU 4
NA
46
FU 24
NA
NA
NA
NA
NA
NA
NA
42
FU 24
NA
NA
NA
NA
NA
NA
NA
NA
NA
49
Week 16
69
FU 20
105
Week 16
75
FU 24
319
FU 4
(Day
204)
274
FU 24
127
FU 24
NA
35
Week 24
49
FU 24
22
Week 24
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
172
FU 4
(Day
220)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.6
233
Week 8
478
Week 7
24
Week 24
29
FU 24
NA
1.8
Week 2
NA
0.7
Week 24
NA
NA
NA
NA
臨床的安全性
-
720
-
総ビリルビン
最大値
最終投
与日又
は最終
観察日
最終投
与日又
は最終
観察日
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:38
胃腸障害の有害事象を発現した患者の詳細一覧（APaT）（043、044 及び 045 試験併合）
本剤投与群
重症度
事象名
悪心
下痢
嘔吐
口内炎
腹部不快感
上腹部痛
便秘
消化不良
口唇炎
齲歯
口内乾燥
胃炎
腹部膨満
腹痛
心窩部不快感
痔核
胃食道逆流性疾患
歯痛
アフタ性口内炎
レッチング
288例
重篤性
治験薬
軽度
中等度
重度
重篤
中止
91
(31.6)
60
(20.8)
62
(21.5)
50
(17.4)
45
(15.6)
29
(10.1)
28
(9.7)
26
(9.0)
17
(5.9)
10
(3.5)
7
(2.4)
6
(2.1)
3
(1.0)
6
(2.1)
2
(0.7)
4
(1.4)
2
(0.7)
2
(0.7)
2
(0.7)
2
(0.7)
9
(3.1)
14
(4.9)
11
(3.8)
8
(2.8)
4
(1.4)
6
(2.1)
5
(1.7)
5
(1.7)
3
(1.0)
1
(0.3)
1
(0.3)
1
(0.3)
3
(1.0)
0
(0)
4
(1.4)
0
(0)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
2
(0.7)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(0.3)
2
(0.7)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
対照群
発現時期
中央値
（範囲）
10
(1-207)
19
(1-326)
34
(1-168)
45
(1-230)
9.5
(1-176)
44.5
(1-252)
51
(1-312)
14.5
(1-203)
63.5
(2-259)
157.5
(21-288)
48
(10-261)
10
(2-117)
35.5
(1-349)
75.5
(2-121)
22.5
(4-69)
125
(14-187)
50
(45-113)
14
(1-76)
62.5
(61-64)
13.5
(12-15)
2.7.4
転帰
重症度
治験薬
回復
未回復
軽度
中等度
重度
重篤
中止
100
(34.7)
75
(26.0)
74
(25.7)
56
(19.4)
47
(16.3)
35
(12.2)
32
(11.1)
31
(10.8)
19
(6.6)
10
(3.5)
7
(2.4)
7
(2.4)
6
(2.1)
6
(2.1)
6
(2.1)
4
(1.4)
2
(0.7)
3
(1.0)
2
(0.7)
2
(0.7)
1
(0.3)
0
(0)
0
(0)
2
(0.7)
2
(0.7)
0
(0)
1
(0.3)
0
(0)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(0.3)
0
(0)
0
(0)
0
(0)
25
(25.5)
19
(19.4)
9
(9.2)
21
(21.4)
8
(8.2)
7
(7.1)
11
(11.2)
4
(4.1)
4
(4.1)
0
(0)
3
(3.1)
3
(3.1)
3
(3.1)
2
(2.0)
1
(1.0)
1
(1.0)
3
(3.1)
2
(2.0)
1
(1.0)
1
(1.0)
2
(2.0)
3
(3.1)
0
(0)
1
(1.0)
2
(2.0)
1
(1.0)
0
(0)
2
(2.0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
臨床的安全性
-
98例
重篤性
721
-
発現時期
中央値
（範囲）
10
(2-422)
30
(1-448)
101.5
(9-289)
51
(3-249)
29
(1-435)
46.5
(5-533)
53
(1-255)
9.5
(2-105)
239
(92-398)
NA
NA
47
(15-168)
27.5
(3-113)
15
(9-129)
4
(4-118)
18.5
(3-34)
168
(168-168)
85
(41-254)
63.5
(7-120)
12
(12-12)
17
(17-17)
転帰
回復
未回復
27
(27.6)
21
(21.4)
9
(9.2)
22
(22.4)
10
(10.2)
7
(7.1)
8
(8.2)
5
(5.1)
3
(3.1)
0
(0)
3
(3.1)
3
(3.1)
3
(3.1)
2
(2.0)
2
(2.0)
1
(1.0)
2
(2.0)
2
(2.0)
1
(1.0)
1
(1.0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
1
(1.0)
3
(3.1)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:38
胃腸障害の有害事象を発現した患者の詳細一覧（APaT）（043、044 及び 045 試験併合）（続き）
本剤投与群
重症度
事象名
硬便
大腸炎
胃ポリープ
消化管運動過剰
肛門脱
びらん性胃炎
大腸ポリープ
マロリー･ワイス症候群
膵嚢胞
腸炎
歯肉腫脹
舌炎
唾液欠乏
痔出血
口腔内潰瘍形成
口唇乾燥
小腸炎
おくび
歯肉出血
歯肉痛
288例
重篤性
治験薬
軽度
中等度
重度
重篤
中止
2
(0.7)
0
(0)
0
(0)
0
(0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
2
(0.7)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
対照群
発現時期
中央値
（範囲）
48
(48-48)
96
(76-116)
153
(153-153)
27
(27-27)
88
(88-88)
143
(143-143)
106
(106-106)
143
(143-143)
176
(176-176)
235
(235-235)
76
(76-76)
71
(71-71)
30
(30-30)
48
(48-48)
5
(5-5)
28
(28-28)
91
(91-91)
45
(45-45)
148
(148-148)
26
(26-26)
2.7.4
転帰
重症度
治験薬
回復
未回復
軽度
中等度
重度
重篤
中止
2
(0.7)
2
(0.7)
0
(0)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
1
(0.3)
0
(0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
臨床的安全性
-
98例
重篤性
722
-
発現時期
中央値
（範囲）
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
186
(186-186)
154
(4-304)
141
(141-141)
92
(92-92)
142
(142-142)
30
(30-30)
421
(421-421)
NA
NA
NA
NA
NA
NA
NA
NA
転帰
回復
未回復
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
2
(2.0)
1
(1.0)
0
(0)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:38
胃腸障害の有害事象を発現した患者の詳細一覧（APaT）（043、044 及び 045 試験併合）（続き）
本剤投与群
重症度
事象名
食道不快感
口腔内痛
口の錯感覚
歯周病
歯根嚢胞
歯の脱落
イレウス
変色便
裂肛
痔瘻
歯不快感
舌痛
唾液変性
歯の障害
288例
重篤性
治験薬
軽度
中等度
重度
重篤
中止
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
対照群
発現時期
中央値
（範囲）
50
(50-50)
128
(128-128)
22
(22-22)
30
(30-30)
26
(26-26)
106
(106-106)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
転帰
重症度
未回復
軽度
中等度
重度
重篤
中止
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
2
(2.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
臨床的安全性
-
治験薬
回復
単位：例数（括弧内は%）［発現時期のみ 単位：日（括弧内は範囲）］
有害事象は1例につき1回のみカウント（同一患者が異なる重症度の同一事象を複数回発現した場合、より重い重症度で1回のみカウント）
2.7.4
98例
重篤性
723
-
発現時期
中央値
（範囲）
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
63
(63-63)
75.5
(38-113)
175
(175-175)
237
(237-237)
223
(223-223)
86
(86-86)
226
(226-226)
371
(371-371)
転帰
回復
未回復
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
1
(1.0)
2
(2.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
0
(0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
有害事象及び副作用発現例数（043、044 及び 045 試験併合）
Patients in population
with one or more adverse events
with no adverse events
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
288
288
287
(99.7)
287
(99.7)
1
(0.3)
1
(0.3)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
98
98
98
(100.0)
98
(100.0)
0
(0.0)
0
(0.0)
Blood and lymphatic system disorders
Anaemia
Eosinophilia
Erythropenia
Febrile neutropenia
Haemolytic anaemia
Hypochromasia
Leukopenia
Lymphopenia
Neutropenia
Thrombocytopenia
Cardiac disorders
Arrhythmia
Atrial fibrillation
Atrioventricular block first degree
Bradycardia
Extrasystoles
Palpitations
Pericarditis
Supraventricular extrasystoles
Ventricular extrasystoles
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
85
63
0
2
1
4
2
9
1
20
4
15
1
3
2
1
1
6
0
1
1
1
1
30
22
1
0
0
2
1
3
1
7
1
6
1
0
0
0
0
2
1
1
1
0
0
(29.5)
(21.9)
(0.0)
(0.7)
(0.3)
(1.4)
(0.7)
(3.1)
(0.3)
(6.9)
(1.4)
(5.2)
(0.3)
(1.0)
(0.7)
(0.3)
(0.3)
(2.1)
(0.0)
(0.3)
(0.3)
(0.3)
(0.3)
2.7.4
84
63
0
2
0
4
2
9
1
20
4
10
1
3
2
1
1
3
0
0
0
0
0
(29.2)
(21.9)
(0.0)
(0.7)
(0.0)
(1.4)
(0.7)
(3.1)
(0.3)
(6.9)
(1.4)
(3.5)
(0.3)
(1.0)
(0.7)
(0.3)
(0.3)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
臨床的安全性
-
724
-
(30.6)
(22.4)
(1.0)
(0.0)
(0.0)
(2.0)
(1.0)
(3.1)
(1.0)
(7.1)
(1.0)
(6.1)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.0)
(1.0)
(1.0)
(1.0)
(0.0)
(0.0)
30
22
1
0
0
2
1
3
1
7
1
4
1
0
0
0
0
2
0
0
1
0
0
(30.6)
(22.4)
(1.0)
(0.0)
(0.0)
(2.0)
(1.0)
(3.1)
(1.0)
(7.1)
(1.0)
(4.1)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.0)
(0.0)
(0.0)
(1.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Ear and labyrinth disorders
Deafness
Deafness neurosensory
Ear discomfort
Endolymphatic hydrops
Meniere's disease
Sudden hearing loss
Tinnitus
Vertigo
Vertigo positional
Endocrine disorders
Autoimmune thyroiditis
Basedow's disease
Hyperthyroidism
Hypothyroidism
Inappropriate antidiuretic hormone
secretion
Thyroid disorder
Thyroid pain
Thyroiditis
Eye disorders
Abnormal sensation in eye
Accommodation disorder
Asthenopia
Blepharitis
Cataract
Chalazion
Conjunctival deposit
Conjunctival haemorrhage
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
18
(6.3)
13
(4.5)
2
(0.7)
2
(0.7)
0
(0.0)
0
(0.0)
2
(0.7)
2
(0.7)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
8
(2.8)
6
(2.1)
6
(2.1)
4
(1.4)
2
(0.7)
1
(0.3)
15
(5.2)
15
(5.2)
3
(1.0)
3
(1.0)
1
(0.3)
1
(0.3)
2
(0.7)
1
(0.3)
5
(1.7)
5
(1.7)
1
(0.3)
1
(0.3)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
11
(11.2)
8
(8.2)
0
(0.0)
0
(0.0)
2
(2.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
5
(5.1)
4
(4.1)
1
(1.0)
1
(1.0)
8
(8.2)
8
(8.2)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
3
(3.1)
3
(3.1)
3
(3.1)
3
(3.1)
0
(0.0)
0
(0.0)
2
1
1
61
1
1
4
3
3
3
1
3
0
0
1
35
0
0
1
3
1
2
0
0
(0.7)
(0.3)
(0.3)
(21.2)
(0.3)
(0.3)
(1.4)
(1.0)
(1.0)
(1.0)
(0.3)
(1.0)
2.7.4
2
1
1
43
1
1
3
2
0
0
0
2
(0.7)
(0.3)
(0.3)
(14.9)
(0.3)
(0.3)
(1.0)
(0.7)
(0.0)
(0.0)
(0.0)
(0.7)
臨床的安全性
-
725
-
(0.0)
(0.0)
(1.0)
(35.7)
(0.0)
(0.0)
(1.0)
(3.1)
(1.0)
(2.0)
(0.0)
(0.0)
0
0
1
26
0
0
1
2
1
0
0
0
(0.0)
(0.0)
(1.0)
(26.5)
(0.0)
(0.0)
(1.0)
(2.0)
(1.0)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Eye disorders
Conjunctival hyperaemia
Conjunctivitis
Conjunctivitis allergic
Corneal erosion
Dry eye
Eye discharge
Eye pain
Eye pruritus
Eyelid oedema
Glaucoma
Keratitis
Lacrimation increased
Ocular discomfort
Ocular hyperaemia
Optic disc haemorrhage
Photophobia
Photopsia
Pingueculitis
Punctate keratitis
Retinal exudates
Retinal haemorrhage
Retinal vascular disorder
Retinopathy
Vision blurred
Visual acuity reduced
Vitreous floaters
Gastrointestinal disorders
Abdominal discomfort
Abdominal distension
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
61
1
5
1
0
15
1
2
2
0
1
0
1
2
0
1
1
2
1
1
3
2
1
12
2
4
2
233
49
6
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(21.2)
43
(14.9)
(0.3)
0
(0.0)
(1.7)
2
(0.7)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(5.2)
9
(3.1)
(0.3)
1
(0.3)
(0.7)
2
(0.7)
(0.7)
1
(0.3)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.7)
1
(0.3)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.7)
1
(0.3)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(1.0)
3
(1.0)
(0.7)
2
(0.7)
(0.3)
1
(0.3)
(4.2)
12
(4.2)
(0.7)
2
(0.7)
(1.4)
3
(1.0)
(0.7)
2
(0.7)
(80.9)
214
(74.3)
(17.0)
47
(16.3)
(2.1)
5
(1.7)
2.7.4
臨床的安全性
-
726
-
n
35
0
4
3
1
2
1
1
2
1
0
1
0
0
1
0
0
0
0
0
1
6
0
12
1
0
3
74
10
3
Placebo + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(35.7)
26
(26.5)
(0.0)
0
(0.0)
(4.1)
1
(1.0)
(3.1)
0
(0.0)
(1.0)
0
(0.0)
(2.0)
1
(1.0)
(1.0)
0
(0.0)
(1.0)
0
(0.0)
(2.0)
2
(2.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(6.1)
6
(6.1)
(0.0)
0
(0.0)
(12.2)
12
(12.2)
(1.0)
1
(1.0)
(0.0)
0
(0.0)
(3.1)
2
(2.0)
(75.5)
65
(66.3)
(10.2)
9
(9.2)
(3.1)
3
(3.1)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Gastrointestinal disorders
Abdominal pain
Abdominal pain upper
Anal fissure
Anal fistula
Anal prolapse
Aphthous stomatitis
Aptyalism
Cheilitis
Colitis
Constipation
Dental caries
Dental discomfort
Diarrhoea
Dry mouth
Dyspepsia
Enteritis
Enterocolitis
Epigastric discomfort
Eructation
Faeces discoloured
Faeces hard
Gastric polyps
Gastritis
Gastritis erosive
Gastrointestinal hypermotility
Gastrooesophageal reflux disease
Gingival bleeding
Gingival pain
Gingival swelling
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
233
6
35
0
0
1
2
1
20
2
33
11
0
75
8
31
1
1
6
1
0
2
1
7
1
1
3
1
1
1
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(80.9)
214
(74.3)
(2.1)
5
(1.7)
(12.2)
29
(10.1)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.7)
2
(0.7)
(0.3)
1
(0.3)
(6.9)
18
(6.3)
(0.7)
1
(0.3)
(11.5)
22
(7.6)
(3.8)
1
(0.3)
(0.0)
0
(0.0)
(26.0)
60
(20.8)
(2.8)
7
(2.4)
(10.8)
29
(10.1)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(2.1)
6
(2.1)
(0.3)
1
(0.3)
(0.0)
0
(0.0)
(0.7)
2
(0.7)
(0.3)
0
(0.0)
(2.4)
6
(2.1)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(1.0)
3
(1.0)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
2.7.4
臨床的安全性
-
727
-
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
74
(75.5)
65
(66.3)
2
(2.0)
1
(1.0)
8
(8.2)
7
(7.1)
1
(1.0)
0
(0.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
4
(4.1)
1
(1.0)
0
(0.0)
0
(0.0)
11
(11.2)
7
(7.1)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
22
(22.4)
19
(19.4)
3
(3.1)
3
(3.1)
6
(6.1)
6
(6.1)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
2
(2.0)
1
(1.0)
0
(0.0)
0
(0.0)
2
(2.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
4
(4.1)
4
(4.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
3
(3.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(2.0)
1
(1.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Gastrointestinal disorders
Glossitis
Glossodynia
Haemorrhoidal haemorrhage
Haemorrhoids
Ileus
Large intestine polyp
Lip dry
Mallory-Weiss syndrome
Mouth ulceration
Nausea
Oesophageal discomfort
Oral pain
Pancreatic cyst
Paraesthesia oral
Periodontal disease
Radicular cyst
Retching
Saliva altered
Stomatitis
Tooth disorder
Tooth loss
Toothache
Vomiting
General disorders and administration site
conditions
Asthenia
Chest discomfort
Chest pain
Chills
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
233
1
0
1
4
0
1
1
1
1
101
1
1
1
1
1
1
2
0
58
0
1
3
74
274
2
6
5
12
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(80.9)
214
(74.3)
(0.3)
1
(0.3)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(1.4)
2
(0.7)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(35.1)
96
(33.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.7)
2
(0.7)
(0.0)
0
(0.0)
(20.1)
55
(19.1)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(1.0)
1
(0.3)
(25.7)
64
(22.2)
(95.1)
271
(94.1)
(0.7)
(2.1)
(1.7)
(4.2)
2.7.4
2
3
3
12
(0.7)
(1.0)
(1.0)
(4.2)
臨床的安全性
-
728
-
n
74
1
1
1
1
1
0
1
0
1
27
0
0
0
0
0
0
1
1
22
1
0
2
9
95
0
0
2
1
Placebo + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(75.5)
65
(66.3)
(1.0)
1
(1.0)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(27.6)
25
(25.5)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(22.4)
21
(21.4)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(2.0)
0
(0.0)
(9.2)
7
(7.1)
(96.9)
95
(96.9)
(0.0)
(0.0)
(2.0)
(1.0)
0
0
1
1
(0.0)
(0.0)
(1.0)
(1.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
General disorders and administration site
conditions
Fatigue
Feeling abnormal
Feeling hot
Feeling jittery
Gait disturbance
Influenza like illness
Injection site anaesthesia
Injection site dermatitis
Injection site erythema
Injection site induration
Injection site inflammation
Injection site pain
Injection site pruritus
Injection site rash
Injection site reaction
Injection site swelling
Injection site warmth
Irritability
Malaise
Oedema
Oedema peripheral
Pain
Pseudopolyp
Pyrexia
Thirst
Vessel puncture site pruritus
Hepatobiliary disorders
Cholelithiasis
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
274
(95.1)
271
(94.1)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
95
(96.9)
95
(96.9)
68
2
2
1
1
27
0
4
31
1
1
1
15
2
72
4
2
1
92
1
1
3
1
212
9
1
18
2
20
1
2
0
1
12
1
3
16
1
0
0
9
4
28
2
1
3
37
0
0
0
0
80
1
0
7
0
(23.6)
(0.7)
(0.7)
(0.3)
(0.3)
(9.4)
(0.0)
(1.4)
(10.8)
(0.3)
(0.3)
(0.3)
(5.2)
(0.7)
(25.0)
(1.4)
(0.7)
(0.3)
(31.9)
(0.3)
(0.3)
(1.0)
(0.3)
(73.6)
(3.1)
(0.3)
(6.3)
(0.7)
2.7.4
67
2
1
1
0
27
0
4
31
1
1
1
15
2
72
4
2
1
91
1
0
1
0
211
7
0
14
2
(23.3)
(0.7)
(0.3)
(0.3)
(0.0)
(9.4)
(0.0)
(1.4)
(10.8)
(0.3)
(0.3)
(0.3)
(5.2)
(0.7)
(25.0)
(1.4)
(0.7)
(0.3)
(31.6)
(0.3)
(0.0)
(0.3)
(0.0)
(73.3)
(2.4)
(0.0)
(4.9)
(0.7)
臨床的安全性
-
729
-
(20.4)
(1.0)
(2.0)
(0.0)
(1.0)
(12.2)
(1.0)
(3.1)
(16.3)
(1.0)
(0.0)
(0.0)
(9.2)
(4.1)
(28.6)
(2.0)
(1.0)
(3.1)
(37.8)
(0.0)
(0.0)
(0.0)
(0.0)
(81.6)
(1.0)
(0.0)
(7.1)
(0.0)
20
0
2
0
1
12
1
3
16
1
0
0
9
4
28
2
1
3
37
0
0
0
0
80
0
0
2
0
(20.4)
(0.0)
(2.0)
(0.0)
(1.0)
(12.2)
(1.0)
(3.1)
(16.3)
(1.0)
(0.0)
(0.0)
(9.2)
(4.1)
(28.6)
(2.0)
(1.0)
(3.1)
(37.8)
(0.0)
(0.0)
(0.0)
(0.0)
(81.6)
(0.0)
(0.0)
(2.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Hepatobiliary disorders
Gallbladder polyp
Hepatic function abnormal
Hepatic steatosis
Hyperbilirubinaemia
Immune system disorders
Seasonal allergy
Infections and infestations
Acute sinusitis
Adenoviral conjunctivitis
Appendicitis
Bacterial infection
Bartholin's abscess
Bronchitis
Cellulitis
Cystitis
Dermatophytosis
Diarrhoea infectious
Enterocolitis infectious
Eye infection
Folliculitis
Gastroenteritis
Gingivitis
Herpes simplex
Herpes zoster
Hordeolum
Impetigo
Infected dermal cyst
Influenza
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
18
0
14
1
1
4
4
118
0
1
1
0
0
5
3
11
1
1
1
0
2
5
4
1
1
3
0
1
2
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(6.3)
14
(4.9)
(0.0)
0
(0.0)
(4.9)
10
(3.5)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(1.4)
1
(0.3)
(1.4)
1
(0.3)
(41.0)
54
(18.8)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.7)
4
(1.4)
(1.0)
2
(0.7)
(3.8)
4
(1.4)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(0.7)
1
(0.3)
(1.7)
1
(0.3)
(1.4)
4
(1.4)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(1.0)
2
(0.7)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.7)
0
(0.0)
2.7.4
臨床的安全性
-
730
-
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
7
(7.1)
2
(2.0)
1
(1.0)
1
(1.0)
4
(4.1)
1
(1.0)
2
(2.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
46
(46.9)
15
(15.3)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
2
(2.0)
0
(0.0)
3
(3.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
4
(4.1)
3
(3.1)
2
(2.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
3
(3.1)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Infections and infestations
Lip infection
Nasal vestibulitis
Nasopharyngitis
Onychomycosis
Oral candidiasis
Oral herpes
Otitis externa
Otitis media
Paronychia
Pericoronitis
Periodontitis
Pharyngitis
Pneumonia
Pneumonia bacterial
Purulence
Rhinitis
Sinusitis
Skin candida
Tinea cruris
Tinea infection
Tinea pedis
Tonsillitis
Tracheobronchitis mycoplasmal
Upper respiratory tract infection
Urinary tract infection
Urinary tract infection bacterial
Vulvovaginal candidiasis
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
118
(41.0)
54
(18.8)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
73
(25.3)
24
(8.3)
0
(0.0)
0
(0.0)
1
(0.3)
0
(0.0)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0.0)
2
(0.7)
1
(0.3)
3
(1.0)
2
(0.7)
1
(0.3)
0
(0.0)
6
(2.1)
1
(0.3)
8
(2.8)
3
(1.0)
2
(0.7)
2
(0.7)
1
(0.3)
1
(0.3)
0
(0.0)
0
(0.0)
1
(0.3)
0
(0.0)
3
(1.0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
4
(1.4)
3
(1.0)
1
(0.3)
0
(0.0)
2
(0.7)
1
(0.3)
0
(0.0)
0
(0.0)
8
(2.8)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
731
-
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
46
(46.9)
15
(15.3)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
31
(31.6)
6
(6.1)
3
(3.1)
0
(0.0)
0
(0.0)
0
(0.0)
3
(3.1)
0
(0.0)
3
(3.1)
2
(2.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
4
(4.1)
3
(3.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
2
(2.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
2
(2.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Injury, poisoning and procedural
complications
Accidental overdose
Animal bite
Ankle fracture
Arthropod bite
Arthropod sting
Cervical vertebral fracture
Contusion
Epicondylitis
Excoriation
Eye contusion
Fall
Hand fracture
Heat stroke
Laceration
Ligament injury
Ligament sprain
Muscle strain
Procedural pain
Rib fracture
Road traffic accident
Spinal compression fracture
Sternal fracture
Sunburn
Thermal burn
Tongue injury
Tooth fracture
Wound
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
31
(10.8)
3
(1.0)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
17
(17.3)
2
(2.0)
6
0
1
2
1
1
8
0
2
0
1
1
1
2
1
1
2
1
2
1
2
1
1
1
1
1
0
6
1
0
0
0
0
1
1
1
1
1
0
0
1
0
1
1
0
0
0
0
0
0
3
0
0
1
(2.1)
(0.0)
(0.3)
(0.7)
(0.3)
(0.3)
(2.8)
(0.0)
(0.7)
(0.0)
(0.3)
(0.3)
(0.3)
(0.7)
(0.3)
(0.3)
(0.7)
(0.3)
(0.7)
(0.3)
(0.7)
(0.3)
(0.3)
(0.3)
(0.3)
(0.3)
(0.0)
2.7.4
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.7)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.3)
(0.0)
(0.0)
臨床的安全性
-
732
-
(6.1)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(1.0)
(1.0)
(1.0)
(1.0)
(1.0)
(0.0)
(0.0)
(1.0)
(0.0)
(1.0)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(3.1)
(0.0)
(0.0)
(1.0)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
1
0
0
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(1.0)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Investigations
Alanine aminotransferase increased
Amylase increased
Aspartate aminotransferase increased
Bilirubin conjugated increased
Blood albumin decreased
Blood alkaline phosphatase increased
Blood bilirubin decreased
Blood bilirubin increased
Blood calcium decreased
Blood calcium increased
Blood chloride increased
Blood cholesterol decreased
Blood cholesterol increased
Blood creatinine decreased
Blood creatinine increased
Blood insulin increased
Blood lactate dehydrogenase increased
Blood phosphorus decreased
Blood phosphorus increased
Blood potassium decreased
Blood potassium increased
Blood pressure decreased
Blood pressure increased
Blood thyroid stimulating hormone
abnormal
Blood thyroid stimulating hormone
decreased
Blood thyroid stimulating hormone
increased
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
225
13
0
10
12
9
10
1
25
25
1
1
1
1
2
2
2
19
14
1
5
3
5
4
0
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(78.1)
218
(75.7)
(4.5)
9
(3.1)
(0.0)
0
(0.0)
(3.5)
8
(2.8)
(4.2)
10
(3.5)
(3.1)
8
(2.8)
(3.5)
10
(3.5)
(0.3)
1
(0.3)
(8.7)
23
(8.0)
(8.7)
25
(8.7)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.7)
2
(0.7)
(0.7)
1
(0.3)
(0.7)
1
(0.3)
(6.6)
13
(4.5)
(4.9)
14
(4.9)
(0.3)
1
(0.3)
(1.7)
5
(1.7)
(1.0)
2
(0.7)
(1.7)
4
(1.4)
(1.4)
2
(0.7)
(0.0)
0
(0.0)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
80
(81.6)
78
(79.6)
7
(7.1)
6
(6.1)
1
(1.0)
1
(1.0)
7
(7.1)
6
(6.1)
2
(2.0)
2
(2.0)
1
(1.0)
1
(1.0)
8
(8.2)
8
(8.2)
0
(0.0)
0
(0.0)
7
(7.1)
7
(7.1)
6
(6.1)
6
(6.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
1
(1.0)
0
(0.0)
6
(6.1)
4
(4.1)
5
(5.1)
5
(5.1)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
3
(1.0)
3
(1.0)
1
(1.0)
1
(1.0)
9
(3.1)
8
(2.8)
11
(11.2)
9
(9.2)
2.7.4
臨床的安全性
-
733
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Investigations
Blood triglycerides increased
Blood urea increased
Blood uric acid decreased
Blood uric acid increased
Blood urine present
C-reactive protein increased
Cell marker increased
Electrocardiogram T wave inversion
Eosinophil count increased
Gamma-glutamyltransferase increased
Glycosylated haemoglobin decreased
Glycosylated haemoglobin increased
Haematocrit decreased
Haemoglobin decreased
High density lipoprotein decreased
Lipids abnormal
Low density lipoprotein decreased
Low density lipoprotein increased
Lymphocyte count decreased
Lymphocyte count increased
Mean cell volume decreased
Monocyte count decreased
Monocyte count increased
Neutrophil count decreased
Platelet count decreased
Protein total decreased
Protein total increased
Protein urine present
Red blood cell count decreased
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
225
4
3
2
18
1
0
4
0
1
20
1
1
15
95
2
0
1
1
11
1
0
1
1
126
88
6
1
1
18
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(78.1)
218
(75.7)
(1.4)
2
(0.7)
(1.0)
2
(0.7)
(0.7)
1
(0.3)
(6.3)
13
(4.5)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(1.4)
4
(1.4)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(6.9)
19
(6.6)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(5.2)
15
(5.2)
(33.0)
95
(33.0)
(0.7)
2
(0.7)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(3.8)
11
(3.8)
(0.3)
1
(0.3)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(43.8)
126
(43.8)
(30.6)
88
(30.6)
(2.1)
5
(1.7)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(6.3)
18
(6.3)
2.7.4
臨床的安全性
-
734
-
n
80
2
1
0
5
0
2
2
1
1
11
1
1
3
42
1
1
0
2
2
0
1
0
0
43
36
3
0
1
7
Placebo + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(81.6)
78
(79.6)
(2.0)
2
(2.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(5.1)
2
(2.0)
(0.0)
0
(0.0)
(2.0)
2
(2.0)
(2.0)
2
(2.0)
(1.0)
0
(0.0)
(1.0)
1
(1.0)
(11.2)
10
(10.2)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(3.1)
3
(3.1)
(42.9)
41
(41.8)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(2.0)
0
(0.0)
(2.0)
2
(2.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(43.9)
43
(43.9)
(36.7)
36
(36.7)
(3.1)
3
(3.1)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(7.1)
7
(7.1)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Investigations
Reticulocyte count decreased
Reticulocyte count increased
Reticulocyte percentage increased
Thyroid function test abnormal
Thyroxine free decreased
Tri-iodothyronine free increased
Tri-iodothyronine increased
Weight decreased
White blood cell count decreased
White blood cell count increased
Metabolism and nutrition disorders
Decreased appetite
Dehydration
Diabetes mellitus
Dyslipidaemia
Glucose tolerance impaired
Hyperchloraemia
Hypercholesterolaemia
Hyperglycaemia
Hyperlipidaemia
Hypernatraemia
Hypertriglyceridaemia
Hyperuricaemia
Hypoalbuminaemia
Hypocalcaemia
Hypoglycaemia
Hypokalaemia
Hypophagia
Hypophosphataemia
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
225
5
5
1
1
1
1
1
33
114
1
101
83
2
1
1
1
1
1
0
2
1
2
6
1
6
1
4
1
3
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(78.1)
218
(75.7)
(1.7)
5
(1.7)
(1.7)
5
(1.7)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(11.5)
30
(10.4)
(39.6)
114
(39.6)
(0.3)
1
(0.3)
(35.1)
96
(33.3)
(28.8)
82
(28.5)
(0.7)
2
(0.7)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(0.7)
1
(0.3)
(0.3)
1
(0.3)
(0.7)
2
(0.7)
(2.1)
5
(1.7)
(0.3)
1
(0.3)
(2.1)
6
(2.1)
(0.3)
0
(0.0)
(1.4)
4
(1.4)
(0.3)
1
(0.3)
(1.0)
3
(1.0)
2.7.4
臨床的安全性
-
735
-
n
80
0
0
0
2
0
0
2
9
45
0
42
35
1
2
0
0
0
0
1
0
0
1
4
1
1
0
1
0
0
Placebo + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(81.6)
78
(79.6)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(2.0)
2
(2.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(2.0)
2
(2.0)
(9.2)
9
(9.2)
(45.9)
45
(45.9)
(0.0)
0
(0.0)
(42.9)
40
(40.8)
(35.7)
34
(34.7)
(1.0)
1
(1.0)
(2.0)
2
(2.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(4.1)
3
(3.1)
(1.0)
1
(1.0)
(1.0)
1
(1.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Metabolism and nutrition disorders
Type 2 diabetes mellitus
Musculoskeletal and connective tissue
disorders
Arthralgia
Arthritis
Back pain
Bone pain
Bursitis
Chondrocalcinosis pyrophosphate
Coccydynia
Intervertebral disc protrusion
Joint swelling
Limb discomfort
Muscle spasms
Muscular weakness
Musculoskeletal chest pain
Musculoskeletal discomfort
Musculoskeletal pain
Musculoskeletal stiffness
Myalgia
Neck pain
Nodal osteoarthritis
Osteoarthritis
Pain in extremity
Periarthritis
Sensation of heaviness
Soft tissue mass
Spinal osteoarthritis
Temporomandibular joint syndrome
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
101
(35.1)
96
(33.3)
1
(0.3)
0
(0.0)
131
(45.5)
112
(38.9)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
42
(42.9)
40
(40.8)
0
(0.0)
0
(0.0)
49
(50.0)
44
(44.9)
73
3
38
0
1
1
1
0
2
1
3
1
1
1
5
10
33
2
1
2
2
1
1
1
1
1
29
0
18
1
0
0
0
1
0
0
2
2
0
0
2
3
12
1
0
1
0
0
0
0
1
0
(25.3)
(1.0)
(13.2)
(0.0)
(0.3)
(0.3)
(0.3)
(0.0)
(0.7)
(0.3)
(1.0)
(0.3)
(0.3)
(0.3)
(1.7)
(3.5)
(11.5)
(0.7)
(0.3)
(0.7)
(0.7)
(0.3)
(0.3)
(0.3)
(0.3)
(0.3)
2.7.4
69
3
26
0
0
1
0
0
0
1
3
1
0
1
3
8
28
2
1
1
1
1
1
0
0
1
(24.0)
(1.0)
(9.0)
(0.0)
(0.0)
(0.3)
(0.0)
(0.0)
(0.0)
(0.3)
(1.0)
(0.3)
(0.0)
(0.3)
(1.0)
(2.8)
(9.7)
(0.7)
(0.3)
(0.3)
(0.3)
(0.3)
(0.3)
(0.0)
(0.0)
(0.3)
臨床的安全性
-
736
-
(29.6)
(0.0)
(18.4)
(1.0)
(0.0)
(0.0)
(0.0)
(1.0)
(0.0)
(0.0)
(2.0)
(2.0)
(0.0)
(0.0)
(2.0)
(3.1)
(12.2)
(1.0)
(0.0)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(1.0)
(0.0)
27
0
15
0
0
0
0
0
0
0
0
2
0
0
0
2
10
1
0
0
0
0
0
0
0
0
(27.6)
(0.0)
(15.3)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(2.0)
(0.0)
(0.0)
(0.0)
(2.0)
(10.2)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Musculoskeletal and connective tissue
disorders
Tenosynovitis
Trigger finger
Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
Endometrial cancer
Gastric cancer
Gastrointestinal submucosal tumour
Haemangioma
Hepatocellular carcinoma
Pyogenic granuloma
Rectal cancer
Uterine leiomyoma
Nervous system disorders
Ageusia
Cervicobrachial syndrome
Cubital tunnel syndrome
Dizziness
Dizziness postural
Dysaesthesia
Dysgeusia
Facial nerve disorder
Head discomfort
Headache
Hyperaesthesia
Hypoaesthesia
Hypogeusia
Intercostal neuralgia
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
131
(45.5)
112
(38.9)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
49
(50.0)
44
(44.9)
1
0
6
(0.3)
(0.0)
(2.1)
0
0
1
(0.0)
(0.0)
(0.3)
0
1
3
(0.0)
(1.0)
(3.1)
0
0
1
(0.0)
(0.0)
(1.0)
1
1
0
0
1
1
1
1
0
175
0
1
1
19
7
1
64
1
0
130
0
5
1
1
(0.3)
(0.3)
(0.0)
(0.0)
(0.3)
(0.3)
(0.3)
(0.3)
(0.0)
(60.8)
(0.0)
(0.3)
(0.3)
(6.6)
(2.4)
(0.3)
(22.2)
(0.3)
(0.0)
(45.1)
(0.0)
(1.7)
(0.3)
(0.3)
0
0
0
0
0
1
0
0
0
165
0
0
0
17
7
0
63
1
0
127
0
3
1
0
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.3)
(0.0)
(0.0)
(0.0)
(57.3)
(0.0)
(0.0)
(0.0)
(5.9)
(2.4)
(0.0)
(21.9)
(0.3)
(0.0)
(44.1)
(0.0)
(1.0)
(0.3)
(0.0)
0
0
1
1
0
0
0
0
1
68
1
0
0
13
1
0
19
0
3
46
1
1
0
0
(0.0)
(0.0)
(1.0)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(1.0)
(69.4)
(1.0)
(0.0)
(0.0)
(13.3)
(1.0)
(0.0)
(19.4)
(0.0)
(3.1)
(46.9)
(1.0)
(1.0)
(0.0)
(0.0)
0
0
1
0
0
0
0
0
0
64
1
0
0
11
0
0
19
0
3
44
0
1
0
0
(0.0)
(0.0)
(1.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(0.0)
(65.3)
(1.0)
(0.0)
(0.0)
(11.2)
(0.0)
(0.0)
(19.4)
(0.0)
(3.1)
(44.9)
(0.0)
(1.0)
(0.0)
(0.0)
2.7.4
臨床的安全性
-
737
-
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Nervous system disorders
Loss of consciousness
Migraine
Muscle contractions involuntary
Neuralgia
Neuropathy peripheral
Occipital neuralgia
Paraesthesia
Parosmia
Restless legs syndrome
Sensory disturbance
Somnolence
Subarachnoid haemorrhage
Syncope
Tension headache
Tremor
Visual field defect
Psychiatric disorders
Abulia
Affect lability
Affective disorder
Aggression
Agoraphobia
Anxiety
Anxiety disorder
Apathy
Boredom
Depressed mood
Depression
Dysthymic disorder
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
175
(60.8)
165
(57.3)
2
(0.7)
1
(0.3)
2
(0.7)
2
(0.7)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0.0)
1
(0.3)
1
(0.3)
5
(1.7)
5
(1.7)
0
(0.0)
0
(0.0)
1
(0.3)
0
(0.0)
4
(1.4)
3
(1.0)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
2
(0.7)
1
(0.3)
0
(0.0)
0
(0.0)
68
(23.6)
58
(20.1)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
4
(1.4)
4
(1.4)
1
(0.3)
0
(0.0)
1
(0.3)
1
(0.3)
3
(1.0)
3
(1.0)
2
(0.7)
2
(0.7)
6
(2.1)
6
(2.1)
1
(0.3)
1
(0.3)
2.7.4
臨床的安全性
-
738
-
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
68
(69.4)
64
(65.3)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
2
(2.0)
2
(2.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(2.0)
1
(1.0)
1
(1.0)
0
(0.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
27
(27.6)
25
(25.5)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
3
(3.1)
3
(3.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2
(2.0)
2
(2.0)
1
(1.0)
1
(1.0)
4
(4.1)
4
(4.1)
1
(1.0)
1
(1.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Psychiatric disorders
Insomnia
Mental disorder
Mood altered
Mood swings
Nervousness
Panic disorder
Panic reaction
Sleep disorder
Taciturnity
Renal and urinary disorders
Calculus urinary
Dysuria
Hydronephrosis
Hypertonic bladder
Nephrolithiasis
Nocturia
Pollakiuria
Proteinuria
Renal cyst
Renal impairment
Reproductive system and breast disorders
Genital discharge
Genital haemorrhage
Menstruation irregular
Ovarian cyst
Vaginal inflammation
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
68
(23.6)
58
(20.1)
51
(17.7)
41
(14.2)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
2
(0.7)
1
(0.3)
1
(0.3)
1
(0.3)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
16
(5.6)
10
(3.5)
1
(0.3)
0
(0.0)
3
(1.0)
1
(0.3)
1
(0.3)
0
(0.0)
1
(0.3)
1
(0.3)
3
(1.0)
3
(1.0)
1
(0.3)
0
(0.0)
5
(1.7)
4
(1.4)
1
(0.3)
1
(0.3)
0
(0.0)
0
(0.0)
1
(0.3)
0
(0.0)
2
(0.7)
0
(0.0)
1
(0.3)
0
(0.0)
0
(0.0)
0
(0.0)
1
(0.3)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
2.7.4
臨床的安全性
-
739
-
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
27
(27.6)
25
(25.5)
20
(20.4)
18
(18.4)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
5
(5.1)
5
(5.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
2
(2.0)
2
(2.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
4
(4.1)
3
(3.1)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
2
(2.0)
2
(2.0)
1
(1.0)
0
(0.0)
1
(1.0)
1
(1.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Respiratory, thoracic and mediastinal
disorders
Allergic bronchitis
Asthma
Cough
Dysphonia
Dyspnoea
Epistaxis
Hyperventilation
Increased upper airway secretion
Interstitial lung disease
Laryngeal discomfort
Laryngeal inflammation
Oropharyngeal discomfort
Oropharyngeal pain
Pharyngeal erythema
Pleural effusion
Pneumonia aspiration
Productive cough
Rhinitis allergic
Rhinorrhoea
Sputum increased
Upper respiratory tract inflammation
Vocal cord thickening
Skin and subcutaneous tissue disorders
Acne
Alopecia
Alopecia areata
Cold sweat
Dandruff
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
77
(26.7)
56
(19.4)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
36
(36.7)
22
(22.4)
0
1
27
2
13
3
1
1
0
0
1
8
26
1
1
1
1
1
3
2
7
1
226
1
91
1
1
1
1
0
14
0
3
3
1
0
1
1
0
3
10
0
0
0
2
1
0
0
3
0
86
0
33
0
0
0
(0.0)
(0.3)
(9.4)
(0.7)
(4.5)
(1.0)
(0.3)
(0.3)
(0.0)
(0.0)
(0.3)
(2.8)
(9.0)
(0.3)
(0.3)
(0.3)
(0.3)
(0.3)
(1.0)
(0.7)
(2.4)
(0.3)
(78.5)
(0.3)
(31.6)
(0.3)
(0.3)
(0.3)
2.7.4
0
0
17
1
12
1
1
0
0
0
1
6
15
0
1
0
1
1
2
2
2
0
217
0
91
1
1
1
(0.0)
(0.0)
(5.9)
(0.3)
(4.2)
(0.3)
(0.3)
(0.0)
(0.0)
(0.0)
(0.3)
(2.1)
(5.2)
(0.0)
(0.3)
(0.0)
(0.3)
(0.3)
(0.7)
(0.7)
(0.7)
(0.0)
(75.3)
(0.0)
(31.6)
(0.3)
(0.3)
(0.3)
臨床的安全性
-
740
-
(1.0)
(0.0)
(14.3)
(0.0)
(3.1)
(3.1)
(1.0)
(0.0)
(1.0)
(1.0)
(0.0)
(3.1)
(10.2)
(0.0)
(0.0)
(0.0)
(2.0)
(1.0)
(0.0)
(0.0)
(3.1)
(0.0)
(87.8)
(0.0)
(33.7)
(0.0)
(0.0)
(0.0)
0
0
12
0
2
1
1
0
1
1
0
2
1
0
0
0
2
0
0
0
2
0
84
0
33
0
0
0
(0.0)
(0.0)
(12.2)
(0.0)
(2.0)
(1.0)
(1.0)
(0.0)
(1.0)
(1.0)
(0.0)
(2.0)
(1.0)
(0.0)
(0.0)
(0.0)
(2.0)
(0.0)
(0.0)
(0.0)
(2.0)
(0.0)
(85.7)
(0.0)
(33.7)
(0.0)
(0.0)
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Skin and subcutaneous tissue disorders
Dermatitis
Dermatitis allergic
Dermatitis atopic
Dermatitis contact
Drug eruption
Dry skin
Dyshidrotic eczema
Eczema
Eczema asteatotic
Eczema nummular
Erythema
Erythema annulare
Haemorrhage subcutaneous
Hand dermatitis
Heat rash
Hyperhidrosis
Hyperkeratosis
Ingrowing nail
Lichen planus
Onychoclasis
Onycholysis
Palmoplantar keratoderma
Pruritus
Pruritus generalised
Psoriasis
Rash
Rash generalised
Rash maculo-papular
Seborrhoeic dermatitis
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
n
226
4
3
2
3
5
18
1
17
3
1
13
0
1
1
1
0
3
0
1
0
1
1
94
5
3
97
1
1
4
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(78.5)
217
(75.3)
(1.4)
3
(1.0)
(1.0)
1
(0.3)
(0.7)
2
(0.7)
(1.0)
0
(0.0)
(1.7)
5
(1.7)
(6.3)
16
(5.6)
(0.3)
0
(0.0)
(5.9)
15
(5.2)
(1.0)
2
(0.7)
(0.3)
1
(0.3)
(4.5)
9
(3.1)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
2
(0.7)
(0.0)
0
(0.0)
(0.3)
0
(0.0)
(0.0)
0
(0.0)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(32.6)
90
(31.3)
(1.7)
5
(1.7)
(1.0)
3
(1.0)
(33.7)
90
(31.3)
(0.3)
1
(0.3)
(0.3)
1
(0.3)
(1.4)
3
(1.0)
2.7.4
臨床的安全性
-
741
-
n
86
4
1
0
0
3
5
0
12
0
1
6
1
0
0
1
1
1
1
0
1
0
0
35
3
0
45
2
0
3
Placebo + Peg-IFN + RBV
Overall
Drug Related†
(%)
n
(%)
(87.8)
84
(85.7)
(4.1)
2
(2.0)
(1.0)
1
(1.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(3.1)
3
(3.1)
(5.1)
4
(4.1)
(0.0)
0
(0.0)
(12.2)
8
(8.2)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(6.1)
5
(5.1)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
0
(0.0)
(1.0)
1
(1.0)
(1.0)
0
(0.0)
(1.0)
0
(0.0)
(0.0)
0
(0.0)
(1.0)
1
(1.0)
(0.0)
0
(0.0)
(0.0)
0
(0.0)
(35.7)
33
(33.7)
(3.1)
3
(3.1)
(0.0)
0
(0.0)
(45.9)
41
(41.8)
(2.0)
2
(2.0)
(0.0)
0
(0.0)
(3.1)
0
(0.0)
バニプレビル カプセル剤
2.7 臨床概要
2.7.4 臨床的安全性
付録 2.7.4:39
Skin and subcutaneous tissue disorders
Skin disorder
Skin erosion
Skin exfoliation
Skin fissures
Swelling face
Toxic skin eruption
Urticaria
Xeroderma
Vascular disorders
Arteriosclerosis
Hot flush
Hypertension
Hypotension
Orthostatic hypotension
Pallor
†
有害事象及び副作用発現例数（043、044 及び 045 試験併合）（続き）
MK-7009 b.i.d. + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
226
(78.5)
217
(75.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
3
(1.0)
2
(0.7)
1
(0.3)
1
(0.3)
1
(0.3)
1
(0.3)
6
(2.1)
3
(1.0)
0
(0.0)
0
(0.0)
13
(4.5)
9
(3.1)
0
(0.0)
0
(0.0)
2
(0.7)
2
(0.7)
11
(3.8)
6
(2.1)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(0.3)
1
(0.3)
Placebo + Peg-IFN + RBV
Overall
Drug Related†
n
(%)
n
(%)
86
(87.8)
84
(85.7)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
1
(1.0)
1
(1.0)
6
(6.1)
3
(3.1)
1
(1.0)
0
(0.0)
1
(1.0)
1
(1.0)
2
(2.0)
1
(1.0)
1
(1.0)
0
(0.0)
1
(1.0)
1
(1.0)
0
(0.0)
0
(0.0)
Determined by the investigator to be related to the drug.
Every patient is counted a single time for each applicable row and column.
A system organ class or specific adverse event appears on this report only if its incidence in one or more of the "Overall" columns meets the incidence criterion in the report title, after rounding.
MK-7009 300 mg b.i.d. + Peg-IFN + RBV: Pooled data of the treatment groups, 12-wk MK-7009 300 mg b.i.d. + Peg-IFN + RBV / 12-wk PBO + Peg-IFN + RBV and 24-wk MK-7009 300 mg b.i.d. +
Peg-IFN + RBV, in protocol 043, 044 and 045
2.7.4
臨床的安全性
-
742
-

in Neutrophils (/microL) Change From Baseline

in Aspartate Aminotransferase (IU/L) Change From Baseline

in Creatinine (mg/dL) Change From Baseline

Document 7467176

Document 7441111

in Hemoglobin (gm/dL) Change From Baseline

意 書に係る必要な検査所 等

Document