3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) Individual Change From Baseline in Creatinine (mg/dl) Over Time (All Patients as Treated) 24

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3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) Individual Change From Baseline in Neutrophils (/microl) Over Time (All Patients as Treated) 24-wk MK-7009 300 mg b.i.d. + Peg-IFN + 10000 5000 in Neutrophils (/microl) Change From Baseline 0-5000 -10000 012345678910112 16 20 24 FU4 FU12 FU20 FU24 Weeks Since Randomization - 563 -

3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) 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 + 0.2 0.1 0.0 in Creatinine (mg/dl) Change From Baseline -0.1-0.2-0.3-0.4-0.5 012345678 10 12 16 20 24 FU4 FU12 FU20 FU24 Weeks Since Randomization - 564 -

3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) Individual Change From Baseline in Aspartate Aminotransferase (IU/L) Over Time (All Patients as Treated) 300 24-wk MK-7009 300 mg b.i.d. + Peg-IFN + 200 Change From Baseline in Aspartate Aminotransferase (IU/L) 100 0-100 -200 012345678 10 12 16 20 24 FU4 FU12 FU20 FU24 Weeks Since Randomization - 565 -

3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) Individual Change From Baseline in Alanine Aminotransferase (IU/L) Over Time (All Patients as Treated) 500 24-wk MK-7009 300 mg b.i.d. + Peg-IFN + 400 300 Change From Baseline in Alanine Aminotransferase (IU/L) 200 100 0-100 -200 012345678 10 12 16 20 24 FU4 FU12 FU20 FU24 Weeks Since Randomization - 566 -

3) ベースラインからの個々の変化量 付録 2.7.4:30 主な臨床検査値の推移 (045 試験 )( 続き ) 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 + 1.5 1.0 Change From Baseline in Bilirubin (mg/dl) 0.5 0.0-0.5-1.0 012345678 10 12 16 20 24 FU4 FU12 FU20 FU24 Weeks Since Randomization - 567 -

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 ]) Placebo + Peg-IFN + MK-7009 300 mg bid + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Patients in population 19 18 20 18 19 with one or more adverse 18 (94.7) 15 (83.3) 18 (90.0) 16 (88.9) 18 (94.7) events with no adverse events 1 (5.3) 3 (16.7) 2 (10.0) 2 (11.1) 1 (5.3) Blood and lymphatic system 4 (21.1) 2 (11.1) 2 (10.0) 0 (0.0) 4 (21.1) disorders Anaemia 3 (15.8) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) Leukopenia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Neutropenia 1 (5.3) 1 (5.6) 2 (10.0) 0 (0.0) 2 (10.5) Pancytopenia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Cardiac disorders 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) Angina pectoris 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Palpitations 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) Tachycardia 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 568 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Ear and labyrinth disorders 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Tinnitus 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Eye disorders 5 (26.3) 3 (16.7) 3 (15.0) 1 (5.6) 2 (10.5) Dry eye 1 (5.3) 1 (5.6) 0 (0.0) 1 (5.6) 1 (5.3) Eye irritation 1 (5.3) 1 (5.6) 1 (5.0) 0 (0.0) 1 (5.3) Eye pain 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Eye pruritus 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Eye swelling 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Lacrimation increased 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Ocular icterus 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Photopsia 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Vision blurred 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Xerophthalmia 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) Gastrointestinal disorders 14 (73.7) 11 (61.1) 14 (70.0) 11 (61.1) 14 (73.7) Abdominal discomfort 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) - 569 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 14 (73.7) 11 (61.1) 14 (70.0) 11 (61.1) 14 (73.7) Abdominal pain 0 (0.0) 0 (0.0) 1 (5.0) 1 (5.6) 0 (0.0) Abdominal pain upper 3 (15.8) 1 (5.6) 2 (10.0) 4 (22.2) 2 (10.5) Anal fissure 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Constipation 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Diarrhoea 4 (21.1) 1 (5.6) 6 (30.0) 2 (11.1) 4 (21.1) Dry mouth 0 (0.0) 1 (5.6) 2 (10.0) 2 (11.1) 1 (5.3) Dyspepsia 4 (21.1) 4 (22.2) 0 (0.0) 2 (11.1) 4 (21.1) Flatulence 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Gastritis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) Gastrooesophageal reflux 1 (5.3) 2 (11.1) 0 (0.0) 2 (11.1) 0 (0.0) disease Gingival bleeding 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Glossodynia 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Haemorrhoids 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Lip dry 2 (10.5) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Nausea 5 (26.3) 5 (27.8) 8 (40.0) 7 (38.9) 6 (31.6) - 570 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 14 (73.7) 11 (61.1) 14 (70.0) 11 (61.1) 14 (73.7) Oesophageal pain 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Stomatitis 1 (5.3) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Vomiting 0 (0.0) 0 (0.0) 8 (40.0) 3 (16.7) 3 (15.8) General disorders and 11 (57.9) 8 (44.4) 11 (55.0) 11 (61.1) 12 (63.2) administration site conditions Asthenia 3 (15.8) 2 (11.1) 2 (10.0) 3 (16.7) 1 (5.3) Chest pain 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) Chills 2 (10.5) 1 (5.6) 1 (5.0) 0 (0.0) 3 (15.8) Discomfort 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Fatigue 7 (36.8) 3 (16.7) 7 (35.0) 4 (22.2) 2 (10.5) Feeling cold 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Feeling of body 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) temperature chan Influenza like illness 4 (21.1) 4 (22.2) 4 (20.0) 4 (22.2) 5 (26.3) - 571 -

General disorders and administration site conditions 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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 11 (57.9) 8 (44.4) 11 (55.0) 11 (61.1) 12 (63.2) Injection site erythema 0 (0.0) 1 (5.6) 2 (10.0) 1 (5.6) 0 (0.0) Injection site irritation 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Injection site reaction 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) Irritability 2 (10.5) 2 (11.1) 1 (5.0) 0 (0.0) 1 (5.3) Oedema peripheral 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Pain 0 (0.0) 0 (0.0) 3 (15.0) 0 (0.0) 0 (0.0) Pyrexia 2 (10.5) 0 (0.0) 1 (5.0) 1 (5.6) 4 (21.1) Infections and infestations 3 (15.8) 2 (11.1) 4 (20.0) 6 (33.3) 5 (26.3) Bronchitis 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Herpes virus infection 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Infected sebaceous cyst 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Nasopharyngitis 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 2 (10.5) Sinusitis 1 (5.3) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) - 572 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 3 (15.8) 2 (11.1) 4 (20.0) 6 (33.3) 5 (26.3) Skin infection 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Tinea infection 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Tracheobronchitis 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Upper respiratory tract 1 (5.3) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) infectio Urinary tract infection 0 (0.0) 0 (0.0) 1 (5.0) 2 (11.1) 1 (5.3) Viral infection 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 1 (5.3) Vulvovaginal mycotic 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) infection Injury, poisoning and 0 (0.0) 0 (0.0) 2 (10.0) 0 (0.0) 1 (5.3) procedural complications Burns second degree 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Contusion 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Post-traumatic pain 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Thermal burn 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) - 573 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Investigations 3 (15.8) 3 (16.7) 3 (15.0) 2 (11.1) 2 (10.5) Blood bilirubin increased 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Blood glucose increased 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Body temperature 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) decreased Body temperature 1 (5.3) 1 (5.6) 0 (0.0) 1 (5.6) 1 (5.3) increased Glucose urine present 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Haemoglobin decreased 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Neutrophil count 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) decreased Weight decreased 1 (5.3) 0 (0.0) 2 (10.0) 0 (0.0) 0 (0.0) White blood cell count 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 1 (5.3) decreased Metabolism and nutrition 2 (10.5) 4 (22.2) 5 (25.0) 2 (11.1) 1 (5.3) disorders Decreased appetite 2 (10.5) 4 (22.2) 5 (25.0) 2 (11.1) 1 (5.3) - 574 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Musculoskeletal and 6 (31.6) 6 (33.3) 4 (20.0) 3 (16.7) 3 (15.8) connective tissue disorders Arthralgia 1 (5.3) 3 (16.7) 2 (10.0) 1 (5.6) 0 (0.0) Back pain 1 (5.3) 0 (0.0) 3 (15.0) 0 (0.0) 2 (10.5) Muscular weakness 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Musculoskeletal chest 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) pain Musculoskeletal pain 0 (0.0) 2 (11.1) 0 (0.0) 2 (11.1) 0 (0.0) Myalgia 3 (15.8) 1 (5.6) 1 (5.0) 1 (5.6) 0 (0.0) Myosclerosis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Pain in extremity 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Nervous system disorders 7 (36.8) 6 (33.3) 10 (50.0) 11 (61.1) 7 (36.8) Cervicobrachial syndrome 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Disturbance in attention 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Dizziness 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Dysgeusia 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 1 (5.3) Head discomfort 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 575 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Nervous system disorders 7 (36.8) 6 (33.3) 10 (50.0) 11 (61.1) 7 (36.8) Headache 7 (36.8) 4 (22.2) 9 (45.0) 8 (44.4) 4 (21.1) Hyperaesthesia 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Memory impairment 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Migraine 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Paraesthesia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Poor quality sleep 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Restless legs syndrome 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) Somnolence 0 (0.0) 0 (0.0) 0 (0.0) 2 (11.1) 1 (5.3) Psychiatric disorders 6 (31.6) 5 (27.8) 2 (10.0) 5 (27.8) 4 (21.1) Abnormal dreams 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Agitation 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Anxiety 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Depressed mood 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Depression 2 (10.5) 1 (5.6) 1 (5.0) 1 (5.6) 0 (0.0) Initial insomnia 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 576 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Psychiatric disorders 6 (31.6) 5 (27.8) 2 (10.0) 5 (27.8) 4 (21.1) Insomnia 2 (10.5) 4 (22.2) 1 (5.0) 3 (16.7) 2 (10.5) Libido decreased 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Mood swings 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Nervousness 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Restlessness 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Sleep disorder 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Renal and urinary disorders 0 (0.0) 2 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) Pollakiuria 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Urine odour abnormal 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Reproductive system and 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 0 (0.0) breast disorders Erectile dysfunction 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Menstrual disorder 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) - 577 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Respiratory, thoracic and 4 (21.1) 4 (22.2) 3 (15.0) 4 (22.2) 4 (21.1) mediastinal disorders Cough 0 (0.0) 2 (11.1) 0 (0.0) 2 (11.1) 0 (0.0) Dry throat 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Dyspnoea 3 (15.8) 3 (16.7) 0 (0.0) 0 (0.0) 2 (10.5) Epistaxis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Nasal congestion 0 (0.0) 1 (5.6) 2 (10.0) 0 (0.0) 0 (0.0) Nasal dryness 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Oropharyngeal pain 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) Productive cough 0 (0.0) 0 (0.0) 2 (10.0) 0 (0.0) 0 (0.0) Rhinorrhoea 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Sinus congestion 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Throat irritation 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Skin and subcutaneous 9 (47.4) 8 (44.4) 5 (25.0) 5 (27.8) 6 (31.6) tissue disorders Alopecia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) - 578 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Skin and subcutaneous 9 (47.4) 8 (44.4) 5 (25.0) 5 (27.8) 6 (31.6) tissue disorders Dermatitis 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Dry skin 3 (15.8) 1 (5.6) 0 (0.0) 1 (5.6) 1 (5.3) Eczema 0 (0.0) 1 (5.6) 1 (5.0) 0 (0.0) 1 (5.3) Erythema 1 (5.3) 1 (5.6) 0 (0.0) 1 (5.6) 0 (0.0) Hyperhidrosis 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Night sweats 1 (5.3) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Pruritus 3 (15.8) 3 (16.7) 0 (0.0) 1 (5.6) 2 (10.5) Rash 4 (21.1) 2 (11.1) 2 (10.0) 3 (16.7) 2 (10.5) Rash papular 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 1 (5.3) Rash vesicular 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Skin burning sensation 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Skin reaction 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Skin ulcer 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6) 0 (0.0) Vascular disorders 1 (5.3) 0 (0.0) 0 (0.0) 1 (5.6) 1 (5.3) - 579 -

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 + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + 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. - 580 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Patients in population 40 42 41 46 42 with one or more adverse 38 (95.0) 42 (100.0) 40 (97.6) 46 (100.0) 41 (97.6) events with no adverse events 2 (5.0) 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.4) Blood and lymphatic system 10 (25.0) 12 (28.6) 13 (31.7) 12 (26.1) 8 (19.0) disorders Anaemia 5 (12.5) 8 (19.0) 8 (19.5) 5 (10.9) 7 (16.7) Anisocytosis 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Leukopenia 2 (5.0) 2 (4.8) 0 (0.0) 1 (2.2) 0 (0.0) Lymphadenitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Lymphadenopathy 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Neutropenia 8 (20.0) 5 (11.9) 3 (7.3) 8 (17.4) 2 (4.8) Thrombocytopenia 1 (2.5) 0 (0.0) 1 (2.4) 1 (2.2) 1 (2.4) - 581 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Cardiac disorders 2 (5.0) 2 (4.8) 0 (0.0) 4 (8.7) 1 (2.4) Bradycardia 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Cardiac failure congestive 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Palpitations 1 (2.5) 0 (0.0) 0 (0.0) 4 (8.7) 1 (2.4) Tachycardia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Congenital, familial and 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) genetic disorders Ichthyosis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Ear and labyrinth disorders 4 (10.0) 2 (4.8) 3 (7.3) 5 (10.9) 0 (0.0) Deafness unilateral 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Ear pain 1 (2.5) 1 (2.4) 1 (2.4) 3 (6.5) 0 (0.0) Hyperacusis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) - 582 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Ear and labyrinth disorders 4 (10.0) 2 (4.8) 3 (7.3) 5 (10.9) 0 (0.0) Hypoacusis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Tinnitus 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Vertigo 3 (7.5) 2 (4.8) 2 (4.9) 1 (2.2) 0 (0.0) Endocrine disorders 1 (2.5) 2 (4.8) 1 (2.4) 4 (8.7) 2 (4.8) Autoimmune thyroiditis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Hyperthyroidism 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Hypothyroidism 1 (2.5) 1 (2.4) 1 (2.4) 3 (6.5) 2 (4.8) Eye disorders 4 (10.0) 3 (7.1) 8 (19.5) 10 (21.7) 4 (9.5) Blepharitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Chalazion 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Conjunctival haemorrhage 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.4) - 583 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Eye disorders 4 (10.0) 3 (7.1) 8 (19.5) 10 (21.7) 4 (9.5) Conjunctivitis 3 (7.5) 0 (0.0) 1 (2.4) 2 (4.3) 1 (2.4) Diplopia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Dry eye 1 (2.5) 0 (0.0) 4 (9.8) 2 (4.3) 2 (4.8) Eczema eyelids 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Eye disorder 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Eye irritation 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Eye pain 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Eye pruritus 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Myopia 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Ocular hyperaemia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Photophobia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Presbyopia 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Retinal detachment 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) - 584 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Eye disorders 4 (10.0) 3 (7.1) 8 (19.5) 10 (21.7) 4 (9.5) Retinal vascular 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) thrombosis Vision blurred 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 0 (0.0) Visual acuity reduced 2 (5.0) 1 (2.4) 0 (0.0) 2 (4.3) 0 (0.0) Visual impairment 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Vitreous floaters 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Xerophthalmia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Abdominal discomfort 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Abdominal distension 1 (2.5) 0 (0.0) 2 (4.9) 2 (4.3) 1 (2.4) Abdominal pain 4 (10.0) 4 (9.5) 3 (7.3) 4 (8.7) 2 (4.8) Abdominal pain lower 1 (2.5) 2 (4.8) 1 (2.4) 0 (0.0) 2 (4.8) Abdominal pain upper 4 (10.0) 7 (16.7) 2 (4.9) 5 (10.9) 5 (11.9) - 585 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Abdominal rigidity 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Abnormal faeces 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Anal fissure 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Aphthous stomatitis 2 (5.0) 3 (7.1) 1 (2.4) 0 (0.0) 2 (4.8) Chapped lips 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Cheilitis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Constipation 2 (5.0) 0 (0.0) 1 (2.4) 3 (6.5) 0 (0.0) Crohn's disease 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Dental caries 1 (2.5) 1 (2.4) 1 (2.4) 1 (2.2) 0 (0.0) Diarrhoea 17 (42.5) 18 (42.9) 13 (31.7) 25 (54.3) 5 (11.9) Dry mouth 3 (7.5) 0 (0.0) 2 (4.9) 2 (4.3) 1 (2.4) Dyspepsia 13 (32.5) 9 (21.4) 9 (22.0) 6 (13.0) 5 (11.9) Dysphagia 1 (2.5) 1 (2.4) 2 (4.9) 0 (0.0) 0 (0.0) - 586 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Epigastric discomfort 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Eructation 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Faeces discoloured 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Flatulence 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Frequent bowel 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) movements Gastritis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Gastritis erosive 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Gastritis haemorrhagic 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Gastrointestinal disorder 2 (5.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Gastrointestinal pain 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Gastrooesophageal reflux 7 (17.5) 3 (7.1) 4 (9.8) 5 (10.9) 1 (2.4) disease Gingival bleeding 0 (0.0) 1 (2.4) 0 (0.0) 2 (4.3) 0 (0.0) - 587 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Gingival pain 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 1 (2.4) Gingivitis 3 (7.5) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Glossitis 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) Glossodynia 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Haemorrhoidal 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) haemorrhage Haemorrhoids 2 (5.0) 2 (4.8) 2 (4.9) 2 (4.3) 1 (2.4) Infrequent bowel 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) movements Lip dry 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Mouth ulceration 1 (2.5) 1 (2.4) 1 (2.4) 3 (6.5) 3 (7.1) Nausea 20 (50.0) 16 (38.1) 13 (31.7) 29 (63.0) 6 (14.3) Oesophageal pain 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 1 (2.4) Oral disorder 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Oral mucosal blistering 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) - 588 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Portal hypertensive 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) gastropathy Proctalgia 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Proctitis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Reflux gastritis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Retching 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Stomatitis 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Tongue ulceration 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Tooth disorder 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Toothache 1 (2.5) 0 (0.0) 2 (4.9) 1 (2.2) 2 (4.8) Upper gastrointestinal 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) haemorrhage Varices oesophageal 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 589 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Gastrointestinal disorders 32 (80.0) 35 (83.3) 32 (78.0) 41 (89.1) 23 (54.8) Vomiting 12 (30.0) 12 (28.6) 5 (12.2) 13 (28.3) 1 (2.4) General disorders and administration site conditions 35 (87.5) 31 (73.8) 34 (82.9) 32 (69.6) 31 (73.8) Asthenia 9 (22.5) 11 (26.2) 10 (24.4) 10 (21.7) 10 (23.8) Chest discomfort 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Chest pain 1 (2.5) 2 (4.8) 0 (0.0) 2 (4.3) 0 (0.0) Chills 2 (5.0) 4 (9.5) 4 (9.8) 1 (2.2) 0 (0.0) Early satiety 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Face oedema 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Fatigue 19 (47.5) 16 (38.1) 18 (43.9) 13 (28.3) 10 (23.8) Feeling abnormal 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) - 590 -

General disorders and administration site conditions 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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 35 (87.5) 31 (73.8) 34 (82.9) 32 (69.6) 31 (73.8) Feeling hot 0 (0.0) 0 (0.0) 3 (7.3) 0 (0.0) 0 (0.0) General physical health 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) deterioration Influenza like illness 10 (25.0) 9 (21.4) 14 (34.1) 10 (21.7) 9 (21.4) Injection site erythema 2 (5.0) 2 (4.8) 2 (4.9) 1 (2.2) 0 (0.0) Injection site 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 0 (0.0) inflammation Injection site pain 1 (2.5) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Injection site pruritus 2 (5.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Injection site reaction 0 (0.0) 1 (2.4) 1 (2.4) 1 (2.2) 1 (2.4) Irritability 3 (7.5) 4 (9.5) 4 (9.8) 5 (10.9) 7 (16.7) Mass 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 591 -

General disorders and administration site conditions 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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 35 (87.5) 31 (73.8) 34 (82.9) 32 (69.6) 31 (73.8) Mucosal dryness 3 (7.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Mucosal inflammation 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Oedema peripheral 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Pain 0 (0.0) 1 (2.4) 2 (4.9) 2 (4.3) 2 (4.8) Pyrexia 6 (15.0) 7 (16.7) 5 (12.2) 10 (21.7) 10 (23.8) Sensation of foreign body 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Spinal pain 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Swelling 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Thirst 1 (2.5) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Hepatobiliary disorders 1 (2.5) 3 (7.1) 2 (4.9) 1 (2.2) 0 (0.0) - 592 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Hepatobiliary disorders 1 (2.5) 3 (7.1) 2 (4.9) 1 (2.2) 0 (0.0) Cholelithiasis 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Hepatic cirrhosis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Hepatomegaly 1 (2.5) 3 (7.1) 0 (0.0) 0 (0.0) 0 (0.0) Immune system disorders 1 (2.5) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) Anaphylactic reaction 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Drug hypersensitivity 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Seasonal allergy 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Abscess limb 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Acute sinusitis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Arthritis infective 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) - 593 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Bronchitis 2 (5.0) 1 (2.4) 2 (4.9) 2 (4.3) 1 (2.4) Candidiasis 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Cellulitis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Conjunctivitis infective 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Conjunctivitis viral 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Cystitis 2 (5.0) 2 (4.8) 2 (4.9) 1 (2.2) 1 (2.4) Diarrhoea infectious 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Ear infection 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Eczema infected 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Folliculitis 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Gastroenteritis 0 (0.0) 2 (4.8) 1 (2.4) 1 (2.2) 0 (0.0) Gastroenteritis viral 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) H1N1 influenza 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 594 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Herpes ophthalmic 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Herpes simplex 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Herpes zoster 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Hordeolum 1 (2.5) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) Infected bites 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Influenza 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Intertrigo candida 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Localised infection 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Lower respiratory tract 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) infection Lung infection 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Nasopharyngitis 0 (0.0) 5 (11.9) 3 (7.3) 4 (8.7) 2 (4.8) Oral fungal infection 1 (2.5) 0 (0.0) 2 (4.9) 0 (0.0) 1 (2.4) - 595 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Oral herpes 1 (2.5) 0 (0.0) 1 (2.4) 3 (6.5) 3 (7.1) Otitis externa 1 (2.5) 2 (4.8) 1 (2.4) 0 (0.0) 0 (0.0) Otitis media 1 (2.5) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Pertussis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Pharyngitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Pharyngitis streptococcal 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Pneumonia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Pyelonephritis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Pyelonephritis acute 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Rhinitis 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 1 (2.4) Sinusitis 2 (5.0) 2 (4.8) 1 (2.4) 4 (8.7) 1 (2.4) Skin infection 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Tinea pedis 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 596 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Tonsillitis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Tooth abscess 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Tooth infection 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Upper respiratory tract 1 (2.5) 5 (11.9) 2 (4.9) 2 (4.3) 4 (9.5) infection Urinary tract infection 2 (5.0) 1 (2.4) 0 (0.0) 2 (4.3) 1 (2.4) Urinary tract infection 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) bacterial Vaginal infection 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Vaginitis bacterial 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Viral infection 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Vulvovaginal candidiasis 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) - 597 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Infections and infestations 12 (30.0) 21 (50.0) 19 (46.3) 21 (45.7) 11 (26.2) Vulvovaginal mycotic 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) infection Wound infection 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Injury, poisoning and 2 (5.0) 5 (11.9) 7 (17.1) 6 (13.0) 7 (16.7) procedural complications Accidental overdose 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 1 (2.4) Animal bite 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Burn oesophageal 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Carbon monoxide 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) poisoning Contusion 1 (2.5) 1 (2.4) 0 (0.0) 2 (4.3) 0 (0.0) Excoriation 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 2 (4.8) Fall 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) - 598 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 2 (5.0) 5 (11.9) 7 (17.1) 6 (13.0) 7 (16.7) Injury, poisoning and procedural complications Femur fracture 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Foot fracture 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Joint sprain 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Laceration 0 (0.0) 1 (2.4) 0 (0.0) 2 (4.3) 0 (0.0) Limb injury 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Muscle strain 1 (2.5) 0 (0.0) 0 (0.0) 1 (2.2) 1 (2.4) Overdose 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Post-traumatic pain 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Road traffic accident 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 1 (2.4) Skeletal injury 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Thermal burn 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Tongue injury 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 599 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Investigations 6 (15.0) 5 (11.9) 7 (17.1) 9 (19.6) 3 (7.1) Alanine aminotransferase 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 1 (2.4) increased Aspartate aminotransferase increased 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 1 (2.4) Blood bilirubin increased 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Blood creatine 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) phosphokinase increased Blood creatinine 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) increased Blood lactate 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) dehydrogenase increased Blood potassium 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) increased Blood thyroid stimulating hormone decreased 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) - 600 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Investigations 6 (15.0) 5 (11.9) 7 (17.1) 9 (19.6) 3 (7.1) Blood thyroid stimulating 1 (2.5) 1 (2.4) 0 (0.0) 2 (4.3) 0 (0.0) hormone increased Blood urine present 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Electrocardiogram QT 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) prolonged Electrocardiogram T 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) wave amplitude increased Gastric ph decreased 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Haemoglobin decreased 0 (0.0) 2 (4.8) 1 (2.4) 0 (0.0) 1 (2.4) Liver function test 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) abnormal Neutrophil count 0 (0.0) 2 (4.8) 1 (2.4) 0 (0.0) 0 (0.0) decreased Platelet count decreased 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) Weight decreased 2 (5.0) 0 (0.0) 5 (12.2) 4 (8.7) 1 (2.4) - 601 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Investigations 6 (15.0) 5 (11.9) 7 (17.1) 9 (19.6) 3 (7.1) Weight increased 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) White blood cell count 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) decreased Metabolism and nutrition 9 (22.5) 15 (35.7) 10 (24.4) 8 (17.4) 3 (7.1) disorders Decreased appetite 8 (20.0) 13 (31.0) 8 (19.5) 5 (10.9) 3 (7.1) Dehydration 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Diabetes mellitus 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Fat intolerance 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Hyperuricaemia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Hypokalaemia 1 (2.5) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Hypomagnesaemia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 602 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Metabolism and nutrition 9 (22.5) 15 (35.7) 10 (24.4) 8 (17.4) 3 (7.1) disorders Type 2 diabetes mellitus 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Musculoskeletal and 18 (45.0) 19 (45.2) 21 (51.2) 23 (50.0) 21 (50.0) connective tissue disorders Amyotrophy 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Arthralgia 7 (17.5) 6 (14.3) 5 (12.2) 8 (17.4) 7 (16.7) Back pain 5 (12.5) 3 (7.1) 3 (7.3) 6 (13.0) 2 (4.8) Bone pain 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Costochondritis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Flank pain 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Muscle fatigue 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.4) Muscle spasms 1 (2.5) 2 (4.8) 4 (9.8) 2 (4.3) 1 (2.4) - 603 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Musculoskeletal and 18 (45.0) 19 (45.2) 21 (51.2) 23 (50.0) 21 (50.0) connective tissue disorders Muscle twitching 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Muscular weakness 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Musculoskeletal chest 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 1 (2.4) pain Musculoskeletal pain 1 (2.5) 1 (2.4) 3 (7.3) 5 (10.9) 1 (2.4) Musculoskeletal stiffness 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Myalgia 4 (10.0) 4 (9.5) 13 (31.7) 11 (23.9) 9 (21.4) Myositis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Neck pain 1 (2.5) 3 (7.1) 1 (2.4) 0 (0.0) 1 (2.4) Osteoporosis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Pain in extremity 0 (0.0) 1 (2.4) 2 (4.9) 2 (4.3) 2 (4.8) Periarthritis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Synovial cyst 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 604 -

Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Malignant melanoma 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Seborrhoeic keratosis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Nervous system disorders 19 (47.5) 20 (47.6) 29 (70.7) 21 (45.7) 17 (40.5) Ageusia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Amnesia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Carotid arteriosclerosis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Carpal tunnel syndrome 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Disturbance in attention 1 (2.5) 1 (2.4) 1 (2.4) 3 (6.5) 1 (2.4) Dizziness 3 (7.5) 5 (11.9) 4 (9.8) 7 (15.2) 5 (11.9) Dizziness postural 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 605 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Nervous system disorders 19 (47.5) 20 (47.6) 29 (70.7) 21 (45.7) 17 (40.5) Dysgeusia 4 (10.0) 3 (7.1) 4 (9.8) 1 (2.2) 1 (2.4) Headache 16 (40.0) 11 (26.2) 21 (51.2) 16 (34.8) 13 (31.0) Hyperaesthesia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Hypoaesthesia 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.2) 0 (0.0) Lethargy 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Memory impairment 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Migraine 1 (2.5) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Neuralgia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 1 (2.4) Paraesthesia 2 (5.0) 0 (0.0) 4 (9.8) 1 (2.2) 0 (0.0) Parosmia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Presyncope 1 (2.5) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Restless legs syndrome 1 (2.5) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Sciatica 2 (5.0) 0 (0.0) 2 (4.9) 1 (2.2) 0 (0.0) - 606 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Nervous system disorders 19 (47.5) 20 (47.6) 29 (70.7) 21 (45.7) 17 (40.5) Sinus headache 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Somnolence 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 1 (2.4) Syncope 0 (0.0) 2 (4.8) 2 (4.9) 0 (0.0) 0 (0.0) Tension headache 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 1 (2.4) Psychiatric disorders 19 (47.5) 20 (47.6) 24 (58.5) 25 (54.3) 17 (40.5) Abnormal dreams 1 (2.5) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Affect lability 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Affective disorder 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Aggression 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 2 (4.8) Anxiety 4 (10.0) 3 (7.1) 1 (2.4) 2 (4.3) 1 (2.4) Apathy 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) Bruxism 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 607 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Psychiatric disorders 19 (47.5) 20 (47.6) 24 (58.5) 25 (54.3) 17 (40.5) Completed suicide 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Depressed mood 1 (2.5) 3 (7.1) 6 (14.6) 2 (4.3) 3 (7.1) Depression 3 (7.5) 7 (16.7) 9 (22.0) 9 (19.6) 1 (2.4) Dysthymic disorder 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Emotional disorder 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Insomnia 7 (17.5) 7 (16.7) 12 (29.3) 6 (13.0) 10 (23.8) Libido decreased 0 (0.0) 1 (2.4) 1 (2.4) 0 (0.0) 0 (0.0) Libido disorder 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Loss of libido 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Major depression 1 (2.5) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Mood altered 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Mood swings 2 (5.0) 2 (4.8) 0 (0.0) 1 (2.2) 0 (0.0) Nervousness 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 0 (0.0) - 608 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Psychiatric disorders 19 (47.5) 20 (47.6) 24 (58.5) 25 (54.3) 17 (40.5) Panic attack 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Sleep disorder 7 (17.5) 5 (11.9) 4 (9.8) 8 (17.4) 4 (9.5) Suicidal ideation 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Renal and urinary disorders 2 (5.0) 2 (4.8) 4 (9.8) 2 (4.3) 3 (7.1) Chromaturia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Dysuria 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Haematuria 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Micturition urgency 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Nephrolithiasis 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 1 (2.4) Nocturia 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Pollakiuria 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 1 (2.4) Polyuria 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 0 (0.0) - 609 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Renal and urinary disorders 2 (5.0) 2 (4.8) 4 (9.8) 2 (4.3) 3 (7.1) Urethral pain 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Urinary retention 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Reproductive system and 0 (0.0) 0 (0.0) 5 (12.2) 3 (6.5) 0 (0.0) breast disorders Erectile dysfunction 0 (0.0) 0 (0.0) 2 (4.9) 1 (2.2) 0 (0.0) Menorrhagia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Menstrual discomfort 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Metrorrhagia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Ovarian cyst 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Vaginal haemorrhage 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Vulvovaginal pruritus 0 (0.0) 0 (0.0) 1 (2.4) 1 (2.2) 0 (0.0) - 610 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 13 (32.5) 22 (52.4) 18 (43.9) 19 (41.3) 16 (38.1) Respiratory, thoracic and mediastinal disorders Asthma 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Cough 5 (12.5) 14 (33.3) 5 (12.2) 13 (28.3) 11 (26.2) Dry throat 0 (0.0) 0 (0.0) 1 (2.4) 2 (4.3) 0 (0.0) Dysphonia 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Dyspnoea 2 (5.0) 6 (14.3) 7 (17.1) 7 (15.2) 4 (9.5) Dyspnoea exertional 2 (5.0) 3 (7.1) 1 (2.4) 3 (6.5) 0 (0.0) Epistaxis 3 (7.5) 1 (2.4) 3 (7.3) 2 (4.3) 1 (2.4) Haemoptysis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Increased viscosity of 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) bronchial secretion Nasal congestion 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 1 (2.4) Nasal dryness 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) - 611 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 13 (32.5) 22 (52.4) 18 (43.9) 19 (41.3) 16 (38.1) Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Oropharyngeal pain 2 (5.0) 1 (2.4) 3 (7.3) 5 (10.9) 2 (4.8) Painful respiration 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Pleural effusion 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Productive cough 1 (2.5) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Rhinitis allergic 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Rhinorrhoea 0 (0.0) 0 (0.0) 1 (2.4) 2 (4.3) 0 (0.0) Throat irritation 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Upper respiratory tract 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) congestion Vocal cord inflammation 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Wheezing 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 1 (2.4) - 612 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Respiratory, thoracic and 13 (32.5) 22 (52.4) 18 (43.9) 19 (41.3) 16 (38.1) mediastinal disorders Yawning 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Skin and subcutaneous 23 (57.5) 26 (61.9) 26 (63.4) 33 (71.7) 21 (50.0) tissue disorders Alopecia 6 (15.0) 4 (9.5) 8 (19.5) 8 (17.4) 3 (7.1) Blister 0 (0.0) 2 (4.8) 0 (0.0) 0 (0.0) 0 (0.0) Chloasma 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.4) Dermal cyst 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Dermatitis 2 (5.0) 2 (4.8) 4 (9.8) 3 (6.5) 0 (0.0) Dermatitis allergic 1 (2.5) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Dermatomyositis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Drug eruption 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) - 613 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 23 (57.5) 26 (61.9) 26 (63.4) 33 (71.7) 21 (50.0) Skin and subcutaneous tissue disorders Dry skin 8 (20.0) 5 (11.9) 5 (12.2) 7 (15.2) 6 (14.3) Ecchymosis 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Eczema 2 (5.0) 3 (7.1) 4 (9.8) 5 (10.9) 5 (11.9) Erythema 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Hair disorder 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Hyperhidrosis 0 (0.0) 2 (4.8) 3 (7.3) 1 (2.2) 1 (2.4) Hyperkeratosis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Increased tendency to 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) bruise Madarosis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Nail discolouration 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Nail disorder 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) Night sweats 0 (0.0) 0 (0.0) 2 (4.9) 0 (0.0) 0 (0.0) - 614 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 23 (57.5) 26 (61.9) 26 (63.4) 33 (71.7) 21 (50.0) Skin and subcutaneous tissue disorders Onychoclasis 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.3) 0 (0.0) Pain of skin 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 1 (2.4) Papule 1 (2.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Photosensitivity reaction 0 (0.0) 3 (7.1) 0 (0.0) 0 (0.0) 0 (0.0) Pruritus 14 (35.0) 13 (31.0) 12 (29.3) 14 (30.4) 9 (21.4) Pruritus generalised 2 (5.0) 2 (4.8) 1 (2.4) 1 (2.2) 2 (4.8) Purpura 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Rash 6 (15.0) 6 (14.3) 6 (14.6) 14 (30.4) 8 (19.0) Rash erythematous 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (4.8) Rash papular 0 (0.0) 2 (4.8) 1 (2.4) 0 (0.0) 1 (2.4) Rash pruritic 0 (0.0) 0 (0.0) 1 (2.4) 2 (4.3) 0 (0.0) Seborrhoeic dermatitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.4) - 615 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + n (%) n (%) n (%) n (%) n (%) 23 (57.5) 26 (61.9) 26 (63.4) 33 (71.7) 21 (50.0) Skin and subcutaneous tissue disorders Skin exfoliation 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Skin fissures 1 (2.5) 2 (4.8) 0 (0.0) 1 (2.2) 0 (0.0) Skin induration 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) 0 (0.0) Skin ulcer 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Swelling face 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Trichorrhexis 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Urticaria 0 (0.0) 1 (2.4) 0 (0.0) 1 (2.2) 1 (2.4) Urticaria physical 0 (0.0) 0 (0.0) 1 (2.4) 0 (0.0) 0 (0.0) Vitiligo 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.2) 0 (0.0) Xeroderma 0 (0.0) 1 (2.4) 1 (2.4) 2 (4.3) 0 (0.0) Vascular disorders 0 (0.0) 3 (7.1) 4 (9.8) 5 (10.9) 1 (2.4) - 616 -

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 PBO + Peg-IFN + 48-wk PBO + Peg-IFN + 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. - 617 -

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 + MK-7009 300 mg bid + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + Patients in population 19 18 20 18 19 With one or more drug-related adverse events Blood and lymphatic system disorders Overall 15 (78.9) 15 (83.3) 18 (90.0) 15 (83.3) 17 (89.5) MK 4 (21.1) 3 (16.7) 5 (25.0) 3 (16.7) 6 (31.6) P+R 15 (78.9) 13 (72.2) 14 (70.0) 12 (66.7) 15 (78.9) MK+P+R 8 (42.1) 8 (44.4) 11 (55.0) 12 (66.7) 8 (42.1) Overall 3 (15.8) 2 (11.1) 2 (10.0) 0 (0.0) 4 (21.1) P+R 3 (15.8) 2 (11.1) 1 (5.0) 0 (0.0) 4 (21.1) MK+P+R 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Anaemia Overall 2 (10.5) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) P+R 2 (10.5) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) - 618 -

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 + MK-7009 300 mg bid + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + Leukopenia Overall 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) P+R 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Neutropenia Overall 1 (5.3) 1 (5.6) 2 (10.0) 0 (0.0) 2 (10.5) P+R 1 (5.3) 1 (5.6) 1 (5.0) 0 (0.0) 2 (10.5) MK+P+R 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) Pancytopenia Overall 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) P+R 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Cardiac disorders Overall 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) P+R 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) MK+P+R 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Angina pectoris 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) - 619 -

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 + MK-7009 300 mg bid + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + Palpitations Overall 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) P+R 0 (0.0) 0 (0.0) 1 (5.0) 0 (0.0) 0 (0.0) MK+P+R 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) Tachycardia 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) Eye disorders Overall 4 (21.1) 3 (16.7) 2 (10.0) 1 (5.6) 2 (10.5) P+R 3 (15.8) 2 (11.1) 2 (10.0) 1 (5.6) 2 (10.5) MK+P+R 2 (10.5) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Dry eye Overall 1 (5.3) 1 (5.6) 0 (0.0) 1 (5.6) 1 (5.3) P+R 0 (0.0) 1 (5.6) 0 (0.0) 1 (5.6) 1 (5.3) MK+P+R 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Eye irritation Overall 1 (5.3) 1 (5.6) 1 (5.0) 0 (0.0) 1 (5.3) - 620 -

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 + MK-7009 300 mg bid + Peg-IFN + MK-7009 600 mg bid + Peg-IFN + MK-7009 600 mg qd + Peg-IFN + MK-7009 800 mg qd + Peg-IFN + Eye irritation P+R 1 (5.3) 0 (0.0) 1 (5.0) 0 (0.0) 1 (5.3) MK+P+R 0 (0.0) 1 (5.6) 0 (0.0) 0 (0.0) 0 (0.0) Eye pain 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) Eye pruritus Overall 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) MK+P+R 1 (5.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Eye swelling 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) Photopsia 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) Vision blurred Overall 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) - 621 -

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