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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- あいり みつだ
- 5 years ago
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1 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 mg b.i.d. + Peg-IFN in Neutrophils (/microl) Change From Baseline FU4 FU12 FU20 FU24 Weeks Since Randomization
2 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 mg b.i.d. + Peg-IFN in Creatinine (mg/dl) Change From Baseline FU4 FU12 FU20 FU24 Weeks Since Randomization
3 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) wk MK mg b.i.d. + Peg-IFN Change From Baseline in Aspartate Aminotransferase (IU/L) FU4 FU12 FU20 FU24 Weeks Since Randomization
4 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) wk MK mg b.i.d. + Peg-IFN Change From Baseline in Alanine Aminotransferase (IU/L) FU4 FU12 FU20 FU24 Weeks Since Randomization
5 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 mg b.i.d. + Peg-IFN Change From Baseline in Bilirubin (mg/dl) FU4 FU12 FU20 FU24 Weeks Since Randomization
6 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK mg qd + Peg-IFN + n (%) n (%) n (%) n (%) n (%) Patients in population 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)
7 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
8 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
9 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
10 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
11 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
12 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
13 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
14 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
15 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
16 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
17 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
18 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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
19 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 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)
20 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)
21 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)
22 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)
23 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)
24 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)
25 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)
26 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)
27 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)
28 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)
29 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)
30 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)
31 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)
32 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)
33 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)
34 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)
35 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)
36 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)
37 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)
38 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)
39 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)
40 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)
41 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)
42 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)
43 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)
44 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)
45 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)
46 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)
47 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)
48 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)
49 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)
50 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)
51 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)
52 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)
53 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)
54 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)
55 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
56 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK mg qd + Peg-IFN + Patients in population 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)
57 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
58 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
59 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 mg bid + Peg-IFN + MK mg bid + Peg-IFN + MK mg qd + Peg-IFN + MK 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)
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4 Endocrine,nutritional and metabolic diseases 内分泌 栄養及び代謝疾患 0401 Disorders of thyroid gland 甲状腺障害 0402 Diabetes mellitus 糖尿病 0403 Other diseases of en
( 海外療養費医科用 ) 給 2- 添付 3 Table of International Classification of Diseases for the use of Social Insurance 社会保険用国際疾病分類表 1 Certain infectious and parasitic diseases 感染症及び寄生虫症 0101 Intestinal infectious diseases
JIPAD2015.pptx
ICU 機能評価委員会報告 JIPAD update 2015 - 過去 現在 そして未来へ - 内野滋彦 東京慈恵会医科大学附属病院集中治療部 x 日本集中治療医学会学術集会 COI 開示 筆頭発表者 : 内野滋彦 1 役員 顧問職等の報酬 * 無 2 株式の利益 * ( または株式の5% 以上 ) 無 3 特許権使用料など * 無 4 講演料など * 無 5 原稿料など * 無 6 研究費 助成金など
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Table of International Classification of Diseases for the use of National Health Insurance 国民健康保険用国際疾病分類表 ⅠCertain infectious and parasitic diseases 感染症及び寄生虫症 0208 Malignant lymphoma 悪性リンパ腫 0101 Intestinal
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21 1 26 1 US6759035University of Southern California 1. A method for decreasing graft rejection of a solid organ by a recipient comprising: a) isolating peripheral blood mononuclear cells (PBMC) from a
健康保険 被保険者家族 ( 海外 ) 療養費支給申請書 被保険者証の 記号被保険者の印氏名と印番号生年月日昭 平年月日歳 被保険 療養が被扶養者のときはその者の氏名被保険者の現住所 - 生年 月日 昭 平 年 月 日 歳 被保険者との続柄 電話 ( ) 者 事業所名称 電話 ( ) が 傷病名 発病又は負傷 の年月日 平成年月日 ( 負傷の場合は AM PM 時頃 ) 記 原因 詳しくご記入ください
CHEMOTHERAPY Table 1 Urinary excretion of mezlocillin Fig. 4 Urinary excretion of mezlocillin Fig. 3 Blood levels of mezlocillin
CHEMOTHERAPY Fig. 2 Urinary excretion of mezlocillin Fig. 1 Blood levels of mezlocillin CHEMOTHERAPY Table 1 Urinary excretion of mezlocillin Fig. 4 Urinary excretion of mezlocillin Fig. 3 Blood levels
Contents. traumatic subarachnoid hemorrhage acute subdural hematoma CT acute epidural hematoma cerebral contusion hemorrhagic contusion 0 DTICH delaye
CT MRI A Ke y t o E m e r g e n c y C T M R I I n t e r p r e t a t i o n 0 脳血管障害救急を要する脳疾患頭部外傷頭頸部脊椎. CT MR MR first subarachnoid hemorrhage 0 acute cerebral infarction vertebral artery dissection Wallenberg
医科的 に診 た外歯瘻 図1 症 例1:右 鼻翼 基 部の瘻 孔 図2 凝 血が付着 して いる 症 例1:初 耳 展 図3 症 例1:抜 歯 後4 50: 1 日 治癒 してい る 右上 犬歯 歯 肉 の発赤 腫 脹 が 見 ら れ る 図4 症 例2:初 図5 頬 部皮 膚の 浸潤 性 発 赤腫 脹 が 見 症 例2:蜂 窩 織 炎 の 所 見 を示 図6 症 例2:初 診 か ら10日 後 に瘻
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Form A This form should be completed and signed by the attending physician. この様式は担当医が書き かつ署名してください One form for each month, one form for hospitalization/outpatient and home visit. 各月ごと 入院 入院外ごとにこの様式が 1
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~2 掴年目月目日 ( 最終被験者の 24 カ月 12.1.6 試験方法本試験は 原発性骨粗鬆症患者を対象に 脆弱性の椎体骨折発生率について のプラセボに対する優越性を検証する 多施設共同 無作為化 二重盲検 プラセボ対照試験である また アレンドロネートを非盲検の参考対照群として設定し の臨床効果の位置付けを探索的に検討した (60 mg Q6M 皮下投与 ) プラセボ(Q6M 皮下投与 ) 又はアレンドロネート(35
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RSD CRPS RSD Reflex Sympathetic Dystrophy 1 RSD RSD 100 1864 1 S. W. Mitchell 1867 causalgia kausos 153 algos 1900 P. H. M. Sudeck Sudeck s atrophy Sudeck post-traumatic pain syndrome sympathetic dystrophy
Key words : 7432-S, Oral cephem, Urinary tract infection Fig. 1. Chemical structure of 7432-S.
Key words : 7432-S, Oral cephem, Urinary tract infection Fig. 1. Chemical structure of 7432-S. Table 1. Clinical summary of acute uncomplicated cystitis patients treated with 7432-S UTI : Criteria by the
VOL. 17 NO. 7 CHEMOTHERAPY 1305 1) W. BRumFirr et al. : Clinical and laboratory studies with carbenicillin. Lancet 1: 1289~ 1293, 1967 2) E. T. KNUDSEN et al. : A new semisynthetic penicillin active against
口腔癌の早期発見のために For the early detection of oral cancer Kazumasa Sugihara Department of Maxillofacial Diagnostic and Surgical Science, Field of Oral and M
Title 口腔癌の早期発見のために Author(s) 杉原, 一正 Citation 鹿児島大学歯学部紀要, 34: 3-11 Issue Date 2014 URL http://hdl.handle.net/10232/20682 http://ir.kagoshima-u.ac.jp 口腔癌の早期発見のために For the early detection of oral cancer Kazumasa
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た費用の額様式第 28 号 ( 第 20 条関係 ) 国民健康保険療養費支給申請書 被保険者証 記号 番号 療養を受けた被保険者氏名 世帯主との続柄 傷病名 一般 退職被保険者等の別 一般 退本 人 退被扶養者 発病又は負傷年月日 平成年月日療養期間 平成 年 月 日から 平成 年 月 日まで 日間 診療 薬剤の支給又は手当を受けた病院 診療所 薬局その他の者の名称及び所在地診療又は調剤に従事した医師
CHEMOTHERAPY APRIL 1992 Table 2. Concentration of meropenem in human prostatic fluid Table 1. Background of 21 chronic complicated UTI cases * NB + BPH, NB + Kidney tumor, NB + Kidney tuberculosis Table
Key words : Adverse reactions, Egg allergy, IgG antibody, Mills allergy, FAST
Key words : Adverse reactions, Egg allergy, IgG antibody, Mills allergy, FAST 13) Danaeus, A., Johansson, S. G. O., Foucard, T. & Ohman, S.: Clinical and immunogical aspects of food allergy in childhood.
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Form A Attending Physician's Statement 診療報酬明細書 東食国保記号番号 :78- - 1. Name of Patient ( Last, First) Age ( Date of Birth ) Sex ( Male Female ) 患者名年齢 ( 生年月日 ) 性別 ( 男 女 ) 2. Name of Illness or Injury preferably
ダラザレックス点滴静注 100 mg ダラザレックス点滴静注 400 mg に関する資料 本資料に記載された情報に係る権利及び内容についての責任は ヤンセンファーマ株式会社に帰属するものであり 当該情報を本薬剤の適正使用以外の営利目的に使用することはできません ヤンセンファーマ株式会社
ダラザレックス点滴静注 100 mg ダラザレックス点滴静注 400 mg に関する資料 本資料に記載された情報に係る権利及び内容についての責任は ヤンセンファーマ株式会社に帰属するものであり 当該情報を本薬剤の適正使用以外の営利目的に使用することはできません ヤンセンファーマ株式会社 1.5 1.5... 3 1 1.5 DVd MM Rd Vd Daratumumab-bortezomib-dexamethasone
CHEMOTHERAPY APR Fig. 2 The inactivation of aminoglycoside antibiotics by PC-904 Fig. 3 Serum concentration of PC-904 (1) Fig. 4 Urinary recover
VOL.26 S-2 CHEMOTHERAPY Gentamicin (GM), Dibekacin (DKB), Tobramycin Fig. 1 Protein concentration and protein binding rate Table 2 Protein binding rate of PC-904 in serum of healthy adults, and patients
MedDRA TERM SELECTION: POINTS TO CONSIDER Release 3. Based on MedDRA version.1 ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactio
MedDRA R 3.5 MedDRA Version 8.1 MedDRA / 2005 11 7 MedDRA TERM SELECTION: POINTS TO CONSIDER Release 3. Based on MedDRA version.1 ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactions
本文／依頼２＿和気先生（４Ｃ） ☆
Ann Jpn Prosthodont Soc 4 : 256-266, 2012 Historical Changes of Psychosomatic Therapy for Patients with Temporomandibular Disorders Hiroyuki Wake, PhD, DDS a, and Osamu Komiyama, PhD, DDS b 256 257 258
1) linisely, M. H. : Postburn Pathologic circulatory Physiology. F. A. Davis Co. philadelphia 1962, 2) James, G. W. et. al. : The anemia of thermal injury : Erythropoiesis and hemoglobin metabolism studied
Request to Attending Physician
REQUEST TO ATTENDING PHYSICIAN 医 科 担当医へのお願い 1. Please fill in this form so that the patient may claim the health social insurance benefit. この様式は患者の健康保険の給付の申請に必要ですので 証明をお願いします 2. This form should be completed
28 1 1a 1b 2 MRI T2 3 CT C3 N95 N95 6ml 90
2015 28 1 89 93 CT C3 Tb PCR XP WBC 7 600/mm 3 CRP 4 08mg/dl MRI MRI CT MRI WBC 9 700/mm 3 CRP 6 09mg/dl CT C3 C2 C7 low density area CT 89 28 1 1a 1b 2 MRI T2 3 CT C3 N95 N95 6ml 90 28 1 4 CT C2 C7 low
1,2) 3-5) 6) 7) Table 1 Table 1 Number of subjects Age (y.o.) Men / Women Weight (kg) Height (cm) Body mass index Systolic BP (mmhg) Diastolic BP (mmh
Received: Jun 19, 2007 Accepted: Dec 6, 2007 Published online: Jan 29, 2008 Original Article The effects of walking with pedometers on quality of life and various symptoms and issues relating to aging
VOL. 34 S-2 CHEMOTH8RAPY 913
VOL. 34 S-2 CHEMOTH8RAPY 913 914 CHEMOTHERAPY APR. 1986 Fig. 1 Chemical structure of T-2588 and T-2525 T- 2588 pivaloyloxymethyl (+ )- (6 R, 7 R)-7-[(Z)-2- (2-amino- 4-thiazolyl)-2-methox yiminoacetamido]-3-[(
Check all corresponding answers. Name INTERNAL MEDICINE Male English year month day Female Date of birth Address year month day Phone Do you have heal
INTERNAL MEDICINE year month day Date of birth Address year month day Phone Do you have health insurance? Nationality YesNo Language What are your symptoms? fever( ) sore throat cough headache chest pain
Clinical Observation and Etiological Aspect on the Thrombocytopenic Purpura after Rubella Toyoji SODA, Masashi KAWANO, Toshihiko KATO*, and Takeshi SH
Clinical Observation and Etiological Aspect on the Thrombocytopenic Purpura after Rubella Toyoji SODA, Masashi KAWANO, Toshihiko KATO*, and Takeshi SHIGEMATSU**, Rubella is an acute viral infectious disease
Title 外傷性脊髄損傷患者の泌尿器科学的研究第 3 報 : 上部尿路のレ線学的研究並びに腎機能について Author(s) 伊藤, 順勉 Citation 泌尿器科紀要 (1965), 11(4): Issue Date URL
Title 外傷性脊髄損傷患者の泌尿器科学的研究第 3 報 : 上部尿路のレ線学的研究並びに腎機能について Author(s) 伊藤, 順勉 Citation 泌尿器科紀要 (1965), 11(4): 278-291 Issue Date 1965-04 URL http://hdl.handle.net/2433/112732 Right Type Departmental Bulletin Paper
Title 泌尿器科領域に於ける17-Ketosteroidの研究 17-Ketosteroidの臨床的研究 第 III 篇 : 尿 Author(s) 卜部, 敏入 Citation 泌尿器科紀要 (1958), 4(1): 3-31 Issue Date URL
Title 泌尿器科領域に於ける17-Ketosteroidの研究 17-Ketosteroidの臨床的研究 第 III 篇 : 尿 Author(s) 卜部, 敏入 Citation 泌尿器科紀要 (1958), 4(1): 3-31 Issue Date 1958-01 URL http://hdl.handle.net/2433/111559 Right Type Departmental Bulletin
Table 1.Distribution and number of cases with acute upper respiratory tract infections classified according to antimicrobial agents administered Table 2. Distribution of cases which were enrolled to set
Table 1 Patients with various renal function * Ccr, Creatinine clearance ml/min per 1. 48 m2 ** C.V.D., Cerebral vascular disease ; C.R F., Chronic renal failure ; H.D., Hemoclialysis ; D., Dialyzer ;
Table 1 Classification of female patients with vesical irritating symptom by their signs : Urinary pain with or without other vesical irritability. s
Table 1 Classification of female patients with vesical irritating symptom by their signs : Urinary pain with or without other vesical irritability. s Vesical irritability without urinary Pain. Pyuria 10/
Form B 1. This form is used for claiming National Health Insurance payments. 様式 B この様式は国民健康保険の給付の申請に使用されます 2. This form should be completed and signed
Form A 1. This form is used for claiming National Health Insurance payments. 様式 A この様式は国民健康保険の給付の申請に使用されます 2. This form should be completed and signed by the attending physician. この様式は担当医が書き かつ署名して下さい
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Current Topics in Diagnostic Imaging of the Pediatric Neck Eiji Oguma, M.D. Department of Radiology, Saitama Children s Medical Center NICHIDOKU-IHO Vol. 49 No. 4 61 83 (2004) Summary This article focuses
4-1 P1: dust 粉塵 4-2 the aerosol エアロゾル 4-3 the vapour 蒸気 4-4 this gas 本ガス 4-5 P2: asthma-like reactions 喘息様反応 4-6 asthma-like reactions (RADS) 喘息様反応 (R
1 Exposure [P1] could cause [P2, and ]. [P1] 暴露すると [P2, and ] を引き起こすことがある 1-1 P1: above the OEL 許容濃度を超えて 1-2 at low levels 低濃度で 1-3 between 200 and 500 ppm 200~500 ppmに 1-4 far above the OEL 許容濃度をはるかに超えて
Fig. 1 Chemical structure of DL-8280
Fig. 1 Chemical structure of DL-8280 Fig. 2 Susceptibility of cl in ical isolates to DL4280 Fig. 5 Susceptibility of clinical isolates to DL-8280 Fig. 3 Susceptibility of clinical isolates to DL-8280 Fig.
Form A 様式 A 1. This form is used for claiming the social insurance benefit. この様式は社会保険の給付の申請に使用されます 2. This form should be completed and signed by the
療養費支給申請書 ( 海外 ) 1 被3 保険5 者7 が記8 入10 する12 とこ13 ろ14 被保険者証の記号 番号 記号 000 番号 0000 ( フリカ ナ ) ケンポタロウ被保険者の ( 申請者 ) 健氏名と印健保太郎印保事業所の名称株式会社 ( 会社名 ) 申請が被扶養者に関すると氏名きはその者の被保険者との続柄 ( ) 傷病名風邪発病又は負傷の原因及び発熱と腹痛があり 病院に行った
日本職業・災害医学会会誌第51巻第5号
太田ら 同時多発性高血圧性脳葉出血の 1 手術例 図 1 搬入時 CT 上段 単純 CT 下段 造影 CT 図 2 術後の脳血管撮影検査では明らかな出血源は認めない 379 Reprint request: MULTIPLE SIMULTANEOUS HYPERTENSIVE LOBAR HEMORRHAGE Hirotsugu OHTA M.D. 1) and Akira YOKOTA M.D.
Recurrent Vertigo with Unilateral or Bilateral Sensorineural Hearing Loss of Unkown Etiology. Tsutomu Yamazaki, Sachie Watanabe, Hideo Kozaki and Taka
Recurrent Vertigo with Unilateral or Bilateral Sensorineural Hearing Loss of Unkown Etiology. Tsutomu Yamazaki, Sachie Watanabe, Hideo Kozaki and Takao Abe (Sapporo General Hosp.) Kazuo Yamamoto (Tomakomai)
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MedDRA 3 CRC 2004 4 24 NPO DSRU Japan kubotape-tky@umin.ac.jp MedDRA Medical Dictionary for Regulatory Activities Terminology MedDRA ICH: International Conference on Harmonisation SOC HLGT HLT PT LLT MedDRA
1) Steinbrocker, O.: The shoulder-hand syndrome in reflex dystrophy of the upper ex- tremity, Ann. Intern. Med., 29: 22, 1948. 5) Greenfield, A. D. M., Whitney, R. J. and Mowbray, J. F.: Methods for the
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Request to Attending Physician 担当医へのお願い 1.Please fill in this from so that the patient may claim the social insurance benefit. この様式は患者の社会保険の給付の申請に必要ですので 証明をお願いします 2.This form should be completed and signed
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- 1 - 35:261-262 2005.12 35:153-154 2005.12-2 - 15500383 15-17 2006.3 [] 1 17(5):161-165 2005.5 32(3):130-134 2005.6 Synovial fringe 1 22(3):322 2005.10 Pancoast 56(13):1663-1666 2005.12 [] 22(5):788-795
CHEMOT HERAPY
CHEMOT HERAPY CHEMOT HERAPY NOV. 1973 Table 1 Co-laboratory clinics CHEMOT HIRAPY 1537 CHEMOT HERAPY NOV. 1973 CHEMOT HERAPY 1539 Table 3 Distribution by age groups No significant difference in age and
VOL.32 S-9 CHEMOTHERAPY Table 1 Minimum inhibitory concentrations of AC-1370, CPZ and CAZ Table 2 Efficacy of AC-1370 and CPZ against systemic infections in mice *Inoculum size: 106 cells/ml * 95% confidence
Table 1 Comparsion of background of the 86 patients with colorectal perforation All Survival Death p-value No. of patients 86 (100%) 74 (86%) 12 (14%)
Japanese Journal of Acute Care Surgery 2013; 3: 55~60 原著 非外傷性大腸穿孔 86 症例の臨床的検討 上田健太郎岩﨑安博山添真志川副友川嶋秀治國立晃成酒谷佳世山上裕機加藤正哉 x 所属 : 和歌山県立医科大学救急集中治療医学講座住所 : 641-8510 和歌山県和歌山市紀三井寺 811-1 Table 1 Comparsion of background
表 E スパイロメーター測定結果 ( 実測値 / 予測値 ) 肺活量 努力性 1 秒量 一秒率 中間 ピークフロー 50% 25% 症例 肺活量 呼気流量 肺活量流量肺活量流量 14 年度 / / / / /
-150- 表 E スパイロメーター測定結果 ( 実測値 / 予測値 ) 肺活量 努力性 1 秒量 一秒率 中間 ピークフロー 50% 25% 症例 肺活量 呼気流量 肺活量流量肺活量流量 14 年度 1 3.68/3.23 3.51/3.23 3.04/3.27 86.6/85.59 3.29/4.16 6.55/6.73 3.49/4.95 1.5/2.9 2 4.76/3.78 4.6/3.78
Effects of the testosterone on both male and female fowls Shohyoe Tsuda Résumé This study was carried out to test the biological actions of androgen on both male and female fowls. As androgen "Amolisin"
Form B 様式 B 1. Please fill in this form so that the patient may claim the health insurance benefit. この様式は患者の健康保険の給付の申請に必要ですので 証明をお願いします 2. This form s
健保組合処理欄 支払年月日 常務理事 事務長 GL 係 法定 円 ( 算式 ) 支払額 付加 1 算定額 疾病コード 資 取得 年 月 日 2 換算額 レート 格 喪失 年 月 日 AAA 被保険者が記入する欄 被保険者 被扶養者 傷病名 ( 傷病部位 ) 症状の概要 海外療養費 ( 法定 付加 ) 支給申請書 事業所名記号 番号 被保険者氏名 被保険者住所受 氏名 診 生年月日 昭 平 年 月 日
1) Barat, I. u. Wagner, R.: Brauer, Beitrage Zur Klinik der Tub., Bd. 71 (1929) 2) Warnecke, F.: Zeitschr. f. Tbk. Bd. 54 (1929) 3) Leoni, Alfonso: Zbl. f. g. Tbk. Forsch. Bd. 33 (1930) 4) Jalavisto, Eva
Fig. 1 Chemical structure of Flurbiprofen Molecular formula : C1S H13 F02 Molecular weight : Chemical name : 2-( 2 -fluoro - 4 -biphenyly1 ) pr
Key words : Flurbiprofen, Acute Upper Respiratory Tract Inflammation, Double-Blind Clinical Evaluation Fig. 1 Chemical structure of Flurbiprofen Molecular formula : C1S H13 F02 Molecular weight : 244.27
Table 1. Antibacterial spectrum SBT ABPC ABPC CPZ : sulbactamiampicillin : ampicillin : cefoperazone
Table 1. Antibacterial spectrum SBT ABPC ABPC CPZ : sulbactamiampicillin : ampicillin : cefoperazone (inoculum size= 106 CFU/ml) (Ĉ-lactamase producer : 2 strains) Fig. 1. Sensitivity distribution of
日本化学療法学会雑誌第51巻第2号
piperacillin piperacillin PIPC. g Cmax CL PIPC CL CLR CLNR CL PIPC g g Cmax PIPC Key words: piperacillin Piperacillin PIPC PIPC g g PIPC Cmax g g ml g g ml g g ml T T T PIPC g g T Ccr ml min AUCCmax PIPC
特集・総説・報告（４４行）／Ｐ０４５－０５５＿報告 日本肝移植研究会
45 Liver Transplantation in Japan in 2006 Part 2 Registry by the The Summary Four thousand three hundred thirty liver transplants have been performed as of December 31, 2006 in 59 institutions in Japan.
5.1.2 デノスマブの用量選択の評価 その他の疾患でのデノスマブの安全性 骨粗鬆症患者 がん患者 腎機能障害患者での安全性解析 外因性要因 薬物相互作用
目次 1. 医薬品への曝露...4 1.1 総括的安全性評価計画及び安全性試験の記述...4 1.1.1 デノスマブの臨床開発計画の概要...4 1.1.1.1 骨巨細胞腫を対象とした臨床開発...4 1.1.1.2 骨巨細胞腫以外の疾患を対象とした臨床開発...6 1.1.2 安全性評価計画の概要...7 1.1.3 試験結果の要約...10 1.2 全般的な曝露状況...10 1.3 治験対象集団の人口統計学的特性及びその他の特性...12
明海大学歯学雑誌 ３７‐２／１．秦泉寺
J Meikai Dent Med 37, 153 158, 8 153 1 7 5ml /1 min Wong-Baker Face Rating Scale FS 5 1 9. g 3 5ml /1 min, FS 1 66 6ml /1 min FS 5 1 9. g 3 6ml /1 min, FS 3 Two Cases of Xerostomia that Showed an Improvement
Bead Instructions First, locate the acupressure point you wish to stimulate. Next, remove a plastic bead from the bag. Remove the backing from the adh
icewave Instructions Bead Instructions First, locate the acupressure point you wish to stimulate. Next, remove a plastic bead from the bag. Remove the backing from the adhesive plastic patch included.
日本職業・災害医学会会誌第54巻第6号
Reprint request: A CASE OF PRESENTED VARIOUS FUNCTIONAL DISTURBANCES AFTER AN INJURY Taketoshi NOGAKI, Nobusuke HOUCHI, Tomoko SUGIUCHI, Naohiko WATANABE and Hiroyuki ZUSHO Department of Otolaryngology,
MeSH MeSH2008 MLA2008 MeSH Q&A
2008 6 MeSH for Searchers MeSH MeSH2008 MLA2008 MeSH Q&A neoplasm neoplasms cancer PubMed neoplasms neoplasms PubMed neoplasms MeSH (1960 2005 ) MeSH A Anatomy B Organisms C Diseases D Chemicals & Drugs
366 12 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 1 8 DNA 2,3 16 12 20 171 2008 12 2010 11 2 3,558 4.44% 1.65% 1.17% 90% 9 Escherichia coli -
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 365 11 sita oxacin 1 1 1 1 1 1 2 2 3 3 1 1 1 2 3 2012 9 14 sita oxacin STFX 50 mg 10% 2008 1 2008 12 2010 11 2 STFX 1,452 91.4% 1,235/1,351 95.9% 466/486
海外療養費の支給申請について
海外療養費の支給申請について 海外の旅先で急病等になり 緊急その他やむを得ない理由で 海外で医療を 受けたときには 帰国後に療養費の申請をすることができます < 手続きの流れ> (1) 受診した海外の医療機関で いったんかかった費用の全額を支払います (2) その医療機関で治療内容及び治療に要した医療費の証明として 診療内容明細書 (FormA) と 領収明細書(FormB) を記入してもらいます
CHEMOTHERAPY JUN Citrobacter freundii 27, Enterobacter aerogenes 26, Enterobacter cloacae 27, Proteus rettgeri 7, Proteus inconstans 20, Proteus
VOL. 32 S-4 CHEMOTHERAPY Fig. 1 Chemical structure of sodium cefoperazone Fig. 2 Chemical structure of sodium cefoperazone CHEMOTHERAPY JUN. 1984 Citrobacter freundii 27, Enterobacter aerogenes 26, Enterobacter
ON A FEW INFLUENCES OF THE DENTAL CARIES IN THE ELEMENTARY SCHOOL PUPIL BY Teruko KASAKURA, Naonobu IWAI, Sachio TAKADA Department of Hygiene, Nippon Dental College (Director: Prof. T. Niwa) The relationship
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2 3 4 5 6 7 8 9 1 2 3 4 5 10 11 12 1 2 1 2 1 2 13 14 3 17 15 1 2 3 D Usefulness of Tc-99m MIBI SPECT in predicting multidrug resistance gene expression level in non-small cell lung cancer a preliminary
【医科：添付書類英語のみ】 海外 療養費・家族療養費 支給申請書
常務理事事務長担当係 海外療養費 家族療養費支給申請書申請日平成年月日 被保険者の 被保険者の住所 渡航先 記 号 番 号 1 被保険者氏名 生年月日昭和 平成年月日 事業所名称 事業所所在地 TEL. - - 印 2 家族が療養を受けた時 4 傷病名 6 発病または負傷の原因 家族氏名 3 続柄生年月日昭和 平成年月日 5 発病または平成年月日負傷の年月日 7 傷病の経過完治 通院中 入院中 療養中
A comparison of abdominal versus vaginal hysterectomy for leiomyoma and adenomyosis Kenji ARAHORI, Hisasi KATAYAMA, Suminori NIOKA Department of Obstetrics and Gnecology, National Maizuru Hospital,Kyoto,
健保決裁欄 理事長常務理事事務長主担者 係員 受付年月日決定年月 海外用 医科 療養費 第二家族療養費 ( 被扶養者 ) 請求書 CNC グループ健康保険組合理事長殿 被保険者証の記号 番号 受診者 被保険者 被保険者資格喪失日平成年月日氏名 ( 喪失後の場合 ) 受診者の生年月日 昭和 平成 年
健保決裁欄 理事長常務理事事務長主担者 係員 受付決定 海外用 医科 療養費 第二家族療養費 ( 被扶養者 ) 請求書 CNC グループ健康保険組合理事長殿 被保険者証の記号 番号 受診者 被保険者 被保険者資格喪失平成氏名 ( 喪失後の場合 ) 受診者の生 昭和 平成 生 傷病名 初診 平成 傷病の原因 症状の概要 退職(予 被 保 険 者 記 入 欄 事業主証明欄 治療の概要 入院 入院外 診療または手当の期間
CHEMOTHERAPY FEB Table 1. Activity of cefpirome and others against clinical isolates
VOL.39 S-1 CHEMOTHERAPY FEB. 1981 Table 1. Activity of cefpirome and others against clinical isolates VOL.39 S-1 CHEMOTHERAPY FEB. 1991 72 M, 55.5 kg 66 F, 53 kg Chronic bronchitis Bronchopneumonia Peak
Kidney Failure - Japanese
Kidney Failure Kidney failure is also called renal failure. With kidney failure, the kidneys cannot get rid of the body s extra fluid and waste. This can happen because of disease or damage from an injury.
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CTD 2.7 Page 193 2.7.4.6 (1) GDDQ 1) GDDQ AGHD GH 14 274 2002 2266 2002 2001 1916 GDDQ 5 139 139 GDDQ *1 0 1 1070 GDDQ 1 2 740 2 3 462 *1 2002 2272 2) GDDQ 140 141 AGHD 44.35 20 2266 2249 1202 1047 141
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No. 98 No. 62 No. 92 No. 60 No. 61 No. 99 GQM No.172 A B GRMRM RM 4B 5 No.337 No.357 No.359 No.112 No.200 151226 25 No. 31 1461 30mg/dl 0.15mg/l mg/dl 20-50 51-100 101-200 201-300 301-400 401-450- 10 No.201
重要データ _ 長期または反復曝露の影響 番号英語日本語訳 1 May cause [P1, and ]. [P1, および ] を引き起こすことがある 1-1 P1: chloracne 塩素座瘡 1-2 fluorosis フッ素沈着症 1-3 hair loss 脱毛 1-4 impaired
![重要データ _ 長期または反復曝露の影響 番号英語日本語訳 1 May cause [P1, and ]. [P1, および ] を引き起こすことがある 1-1 P1: chloracne 塩素座瘡 1-2 fluorosis フッ素沈着症 1-3 hair loss 脱毛 1-4 impaired](/thumbs/94/122225762.jpg "重要データ _ 長期または反復曝露の影響 番号英語日本語訳 1 May cause [P1, and ]. [P1, および ] を引き起こすことがある 1-1 P1: chloracne 塩素座瘡 1-2 fluorosis フッ素沈着症 1-3 hair loss 脱毛 1-4 impaired")
1 May cause [P1, and ]. [P1, および ] を引き起こすことがある 1-1 P1: chloracne 塩素座瘡 1-2 fluorosis フッ素沈着症 1-3 hair loss 脱毛 1-4 impaired vision 視覚障害 1-5 photosensitization 光感作 1-6 severe lung damage 重篤な肺障害 1-7 systemic
From the Department of Pharmacology, Okayama University Medical School (Director: Prof. H. Yamasaki) Studies on Synthetic Anthelmintics Part 4. Toxicologic Studies on Alkylresorcinols and Alkylchlororesorcinols
名称未設定-1
Study on Clinical Factors Affecting the Fungal Culture Test - Relevance of Dry Mouth - Yoshiko YAMAMURA, Yukihiro MOMOTA, Hideyuki TAKANO, Koichi KANI, Katsumi MOTEGI, Fumihiro MATSUMOTO, Masayuki AZUMA
Fig. 1 Clinical findings and extent of inflammation area in female urethrocystitis Fig. 2 Classification and distribution of female patients with blad
Key words: Female with bladder irritability, Subjective symptoms, Pyuria, Bacteriuria Fig. 1 Clinical findings and extent of inflammation area in female urethrocystitis Fig. 2 Classification and distribution
海外療養費申請時の注意事項 海外療養費の申請は 基本的に国内で自費診療をした際に申請する療養費支 給申請に準じております しかし 国内と海外との医療制度の相違などにより 国内で診療を受けた場合と申請書類が少々異なりますのでご注意下さい 海外療養費申請書類 下記の書類すべてをご提出下さい 1 療養費支
海外療養費申請時の注意事項 海外療養費の申請は 基本的に国内で自費診療をした際に申請する療養費支 給申請に準じております しかし 国内と海外との医療制度の相違などにより 国内で診療を受けた場合と申請書類が少々異なりますのでご注意下さい 海外療養費申請書類 下記の書類すべてをご提出下さい 1 療養費支給申請書 被保険者本人が記入 2 診療内容明細書 ( 様式 A 歯科は様式 C) 治療担当医が記入 3
Ⅰ. Statistics Concerning Health Birthweight (1) Birthweight by year (2) Mean birthweight by prefecture, 2007-1997 (3) Percentage of births under 2,500g by prefecture, 2007-1997 Sex Ratio (4) Sex ratio
2) Dolphin, A., Jenner, P., Marsden, C,D., Pycock, C. and Tarsy, D. : Pharmacological evidence for cerebral dopamine receptor blockade by metoclopramide in rodents, Psychopharmacologia, 41 : 133, 1975.
Fig. 1 Clinical course of case 1
Key words: MRSA, TSS, TSST-1, phage type Fig. 1 Clinical course of case 1 1149 昭 和61年10月20日 Table 1 Antibiotic eus (3 density Table 2 Phage sensitivity and toxic type of S, aureus 示 す ご と く,本 菌 はMRSAで
Table 1. Influence of urine ph on MBCs of new quinolones against Escherichia coli NIHJ JC-2 and Pseudomonas aeruginosa 18S; MBCs in urine were compared with those in Miieller-Hinton broth. Table 2. Influence
Endocrinological and statistical analysis of ovarian function in hysterectomized patients Masaya HAYAFUJI, Kazuaki KATAYAMA and Matsuto MOCHIZUKI Depa
Endocrinological and statistical analysis of ovarian function in hysterectomized patients Masaya HAYAFUJI, Kazuaki KATAYAMA and Matsuto MOCHIZUKI Department of Obstetrics and Gynecology, Kobe University
Relationship Between One-minute Oscillation in The Oxygen Saturation Level of The Blood and The Hemoglobin Volume in The Muscular Tissue in The Lower
SURE: Shizuoka University REp http://ir.lib.shizuoka.ac.jp/ Title 直 立 時 のヒト 下 腿 筋 組 織 における 血 液 酸 素 飽 和 度 及 び 総 ヘモグロビン 量 の1 分 変 動 と 体 液 量 変 動 1 分 波 との 関 係 Author(s) 稲 村, 欣 作 ; 間 野, 忠 明 ; 岩 瀬, 敏 ; 天 岸, 祥
Table 1 Classification of female patients with vealcal irritating symptom by their signs Urination pain with other vesical irritability or not Table 2 Serum levels of DL-8280 after a single oral administration
研究成果報告書(基金分)
(1) 種類 程度 肥満細胞数の測定と組織でのサ RT-PCR FACS () (1) NMU-/- IgE NMU IgE -/-NMU -/-B IgE NMU -/-B6 IgE NMU NMU CTLMC BMMC IgE NMU CTLMC 13 1. Hayakawa J, Mizukawa Y, Kurata M, Shiohara T: A syringotropic variant
( ( ) ) 受付年月日 年 月 日 伺年月日 年 月 日 支 給 支 払 決 議 書 決済年月日年月日 支給額円 支給期間 自年月日資格取得年月日 至年月日資格喪失年月日 日間支払年月日年月日 これに要した費用の 領収書 を添付して下さい 輸血及びコル セット等治療用装具に関する申請の時は 医師
( ( ) ) 受付年月日 年 月 日 伺年月日 年 月 日 支 給 支 払 決 議 書 決済年月日年月日 支給額円 支給期間 自年月日資格取得年月日 至年月日資格喪失年月日 日間支払年月日年月日 これに要した費用の 領収書 を添付して下さい 輸血及びコル セット等治療用装具に関する申請の時は 医師の証明書 のほか 注意事項 被保険者証の 記号 番号 第 号 傷病名 発病または負傷の原因 傷病の経過
1-4) 1) Fuscoporia obliqua 5,6) 2,8,9)
ANTI-AGING MEDICINE Received: Jan 29, 2007 Accepted: May 19, 2007 Published online: June 1, 2007 Original Article Double Blind Study of Health Claims for Food Containing Extract of Kabanoanatake (Charga:
Table 1 Epidemiologic characteristics in the elderly patients with sepsis Table 2 Main underlying disease
Key words: elderly patient, sepsis, multiple organ failure (MOF) Table 1 Epidemiologic characteristics in the elderly patients with sepsis 1985-1994 Table 2 Main underlying disease Fig. 1 The yearly frequency