26 GS-US-320-0101 試験
26.6 付録 TEAE
26.6.1
表2.7.6.26 - 14 GS-US-320-0101試験：すべてのTEAE（安全性解析対象集団）
8 MG TAF (N=10)
25 MG TAF (N=10) QD
40 MG TAF (N=11) QD
120 MG TAF (N=10) QD
300 MG TDF (N=10) QD Number of Subjects Experiencing any
Treatment-Emergent Adverse Event 7 ( 70.0%) 6 ( 60.0%) 6 ( 54.5%) 8 ( 80.0%) 5 ( 50.0%)
Number of Subjects Experiencing any
Treatment-Emergent Adverse Event by System Organ Class and Preferred Term
EYE DISORDERS 眼障害 1 ( 10.0%) 1 ( 10.0%) 0 0 0
CONJUNCTIVITIS 結膜炎 1 ( 10.0%) 0 0 0 0
EYE CONTUSION 眼挫傷 0 1 ( 10.0%) 0 0 0
OCULAR HYPERAEMIA 眼充血 0 1 ( 10.0%) 0 0 0
GASTROINTESTINAL DISORDERS 胃腸障害 5 ( 50.0%) 4 ( 40.0%) 1 ( 9.1%) 3 ( 30.0%) 2 ( 20.0%)
NAUSEA 悪心 2 ( 20.0%) 1 ( 10.0%) 1 ( 9.1%) 0 1 ( 10.0%)
CONSTIPATION 便秘 3 ( 30.0%) 0 0 1 ( 10.0%) 0
FLATULENCE 鼓腸 1 ( 10.0%) 1 ( 10.0%) 0 1 ( 10.0%) 0
ABDOMINAL DISTENSION 腹部膨満 1 ( 10.0%) 1 ( 10.0%) 0 0 0
VOMITING 嘔吐 0 1 ( 10.0%) 0 1 ( 10.0%) 0
CHANGE OF BOWEL HABIT 便習慣変化 0 1 ( 10.0%) 0 0 0
DIARRHOEA 下痢 0 1 ( 10.0%) 0 0 0
DRY MOUTH 口内乾燥 1 ( 10.0%) 0 0 0 0
DYSPEPSIA 消化不良 0 0 0 0 1 ( 10.0%)
EPIGASTRIC DISCOMFORT 心窩部不快感 0 1 ( 10.0%) 0 0 0
GASTROOESOPHAGEAL REFLUX DISEASE 胃食道逆流性疾患 1 ( 10.0%) 0 0 0 0
8 MG TAF (N=10)
25 MG TAF (N=10) QD
40 MG TAF (N=11) QD
120 MG TAF (N=10) QD
300 MG TDF (N=10) QD GENERAL DISORDERS AND ADMINISTRATION
SITE CONDITIONS 一般・全身障害および投与部位の状
態 3 ( 30.0%) 2 ( 20.0%) 3 ( 27.3%) 3 ( 30.0%) 1 ( 10.0%)
FATIGUE 疲労 3 ( 30.0%) 1 ( 10.0%) 2 ( 18.2%) 3 ( 30.0%) 1 ( 10.0%)
CHEST DISCOMFORT 胸部不快感 0 0 1 ( 9.1%) 0 0
INFLUENZA LIKE ILLNESS インフルエンザ様疾患 0 0 0 1 ( 10.0%) 0
VESSEL PUNCTURE SITE PAIN 血管穿刺部位疼痛 0 1 ( 10.0%) 0 0 0
VESSEL PUNCTURE SITE SWELLING 血管穿刺部位腫脹 0 1 ( 10.0%) 0 0 0
INFECTIONS AND INFESTATIONS 感染症および寄生虫症 2 ( 20.0%) 1 ( 10.0%) 1 ( 9.1%) 2 ( 20.0%) 1 ( 10.0%)
FOLLICULITIS 毛包炎 0 0 0 1 ( 10.0%) 1 ( 10.0%)
ANAL ABSCESS 肛門膿瘍 1 ( 10.0%) 0 0 0 0
INFLUENZA インフルエンザ 0 0 0 1 ( 10.0%) 0
NASOPHARYNGITIS 鼻咽頭炎 0 0 1 ( 9.1%) 0 0
OTITIS MEDIA 中耳炎 0 0 0 0 1 ( 10.0%)
VIRAL UPPER RESPIRATORY TRACT
INFECTION ウイルス性上気道感染 0 1 ( 10.0%) 0 0 0
VULVOVAGINAL CANDIDIASIS 外陰部腟カンジダ症 1 ( 10.0%) 0 0 0 0
INJURY, POISONING AND PROCEDURAL
COMPLICATIONS 傷害、中毒および処置合併症 0 0 1 ( 9.1%) 1 ( 10.0%) 0
CONTUSION 挫傷 0 0 0 1 ( 10.0%) 0
MUSCLE STRAIN 肉離れ 0 0 0 1 ( 10.0%) 0
PROCEDURAL DIZZINESS 処置によるめまい 0 0 1 ( 9.1%) 0 0
VESSEL PUNCTURE SITE BRUISE 血管穿刺部位内出血 0 0 1 ( 9.1%) 0 0
METABOLISM AND NUTRITION DISORDERS 代謝および栄養障害 0 0 0 0 1 ( 10.0%)
INCREASED APPETITE 食欲亢進 0 0 0 0 1 ( 10.0%)
MUSCULOSKELETAL AND CONNECTIVE
TISSUE DISORDERS 筋骨格系および結合組織障害
3 ( 30.0%) 1 ( 10.0%) 0 1 ( 10.0%) 1 ( 10.0%)
ARTHRALGIA 関節痛 1 ( 10.0%) 0 0 0 1 ( 10.0%)
8 MG TAF (N=10)
25 MG TAF (N=10) QD
40 MG TAF (N=11) QD
120 MG TAF (N=10) QD
300 MG TDF (N=10) QD
MYALGIA 筋肉痛 1 ( 10.0%) 0 0 1 ( 10.0%) 0
BACK PAIN 背部痛 0 1 ( 10.0%) 0 0 0
FLANK PAIN 側腹部痛 1 ( 10.0%) 0 0 0 0
MUSCULAR WEAKNESS 筋力低下 1 ( 10.0%) 0 0 0 0
MUSCULOSKELETAL PAIN 筋骨格痛 0 1 ( 10.0%) 0 0 0
PAIN IN EXTREMITY 四肢痛 0 1 ( 10.0%) 0 0 0
NERVOUS SYSTEM DISORDERS 神経系障害 3 ( 30.0%) 4 ( 40.0%) 2 ( 18.2%) 4 ( 40.0%) 2 ( 20.0%)
HEADACHE 頭痛 2 ( 20.0%) 3 ( 30.0%) 1 ( 9.1%) 3 ( 30.0%) 1 ( 10.0%)
DIZZINESS 浮動性めまい 0 1 ( 10.0%) 0 1 ( 10.0%) 2 ( 20.0%)
LETHARGY 嗜眠 0 1 ( 10.0%) 1 ( 9.1%) 0 0
DYSGEUSIA 味覚異常 0 0 0 0 1 ( 10.0%)
MEMORY IMPAIRMENT 記憶障害 0 0 0 1 ( 10.0%) 0
MIGRAINE 片頭痛 1 ( 10.0%) 0 0 0 0
PRESYNCOPE 失神寸前の状態 0 1 ( 10.0%) 0 0 0
SOMNOLENCE 傾眠 0 0 1 ( 9.1%) 0 0
PSYCHIATRIC DISORDERS 精神障害 4 ( 40.0%) 0 0 1 ( 10.0%) 0
ANXIETY 不安 1 ( 10.0%) 0 0 0 0
INSOMNIA 不眠症 1 ( 10.0%) 0 0 0 0
LOSS OF LIBIDO リビド消失 1 ( 10.0%) 0 0 0 0
SLEEP DISORDER 睡眠障害 0 0 0 1 ( 10.0%) 0
TENSION 緊張 1 ( 10.0%) 0 0 0 0
RENAL AND URINARY DISORDERS 腎および尿路障害 1 ( 10.0%) 0 0 0 1 ( 10.0%)
DYSURIA 排尿困難 1 ( 10.0%) 0 0 0 0
POLYURIA 多尿 0 0 0 0 1 ( 10.0%)
REPRODUCTIVE SYSTEM AND BREAST 生殖系および乳房障害 0 0 1 ( 9.1%) 0 0
8 MG TAF (N=10)
25 MG TAF (N=10) QD
40 MG TAF (N=11) QD
120 MG TAF (N=10) QD
300 MG TDF (N=10) QD DISORDERS
METRORRHAGIA 不正子宮出血 0 0 1 ( 9.1%) 0 0
RESPIRATORY, THORACIC AND MEDIASTINAL
DISORDERS 呼吸器、胸郭および縦隔障害 1 ( 10.0%) 3 ( 30.0%) 2 ( 18.2%) 0 2 ( 20.0%)
COUGH 咳嗽 1 ( 10.0%) 1 ( 10.0%) 2 ( 18.2%) 0 0
OROPHARYNGEAL PAIN 口腔咽頭痛 1 ( 10.0%) 0 0 0 1 ( 10.0%)
RHINORRHOEA 鼻漏 0 1 ( 10.0%) 0 0 1 ( 10.0%)
DYSPNOEA 呼吸困難 0 1 ( 10.0%) 0 0 0
NASAL CONGESTION 鼻閉 0 0 1 ( 9.1%) 0 0
SKIN AND SUBCUTANEOUS TISSUE
DISORDERS 皮膚および皮下組織障害 1 ( 10.0%) 0 0 1 ( 10.0%) 0
RASH 発疹 0 0 0 1 ( 10.0%) 0
SKIN FISSURES 皮膚亀裂 1 ( 10.0%) 0 0 0 0
VASCULAR DISORDERS 血管障害 1 ( 10.0%) 0 0 1 ( 10.0%) 0
HOT FLUSH ほてり 1 ( 10.0%) 0 0 0 0
HYPERTENSION 高血圧 0 0 0 1 ( 10.0%) 0
Data Extracted: 21AUG2013
Source: /u/gs7340/adhoc/req7941/prog/r-req7941-t-teae-3200101.sas v9.2 Output file: t-teae-all-s3200101.out 24FEB2016:13:10
表2.7.6.26 - 15 GS-US-320-0101試験：治験責任医師により治験薬と関連ありと判断されたすべてのTEAE（安全性解析対象集団）
8 MG TAF
(N=10) 25 MG TAF
QD (N=10) 40 MG TAF
QD (N=11) 120 MG TAF
QD (N=10) 300 MG TDF QD (N=10) Number of Subjects Experiencing any Treatment-Emergent Treatment-Related Adverse Events 2 ( 20.0%) 4 ( 40.0%) 3 ( 27.3%) 4 ( 40.0%) 5 ( 50.0%) Number of Subjects Experiencing any Treatment-Emergent Treatment-Related Adverse Events by
System Organ Class and Preferred Term
GASTROINTESTINAL DISORDERS 胃腸障害 2 ( 20.0%) 2 ( 20.0%) 1 ( 9.1%) 2 ( 20.0%) 2 ( 20.0%)
NAUSEA 悪心 2 ( 20.0%) 1 ( 10.0%) 1 ( 9.1%) 0 1 ( 10.0%)
FLATULENCE 鼓腸 1 ( 10.0%) 0 0 1 ( 10.0%) 0
VOMITING 嘔吐 0 1 ( 10.0%) 0 1 ( 10.0%) 0
ABDOMINAL DISTENSION 腹部膨満 0 1 ( 10.0%) 0 0 0
CHANGE OF BOWEL HABIT 便習慣変化 0 1 ( 10.0%) 0 0 0
CONSTIPATION 便秘 1 ( 10.0%) 0 0 0 0
DYSPEPSIA 消化不良 0 0 0 0 1 ( 10.0%)
GENERAL DISORDERS AND ADMINISTRATION
SITE CONDITIONS 一般・全身障害および投与部位の状
態 0 0 1 ( 9.1%) 1 ( 10.0%) 1 ( 10.0%)
FATIGUE 疲労 0 0 1 ( 9.1%) 1 ( 10.0%) 1 ( 10.0%)
INFECTIONS AND INFESTATIONS 感染症および寄生虫症 0 0 0 1 ( 10.0%) 1 ( 10.0%)
INFLUENZA インフルエンザ 0 0 0 1 ( 10.0%) 0
OTITIS MEDIA 中耳炎 0 0 0 0 1 ( 10.0%)
METABOLISM AND NUTRITION DISORDERS 代謝および栄養障害 0 0 0 0 1 ( 10.0%)
INCREASED APPETITE 食欲亢進 0 0 0 0 1 ( 10.0%)
MUSCULOSKELETAL AND CONNECTIVE TISSUE
DISORDERS 筋骨格系および結合組織障害
1 ( 10.0%) 1 ( 10.0%) 0 1 ( 10.0%) 0
ARTHRALGIA 関節痛 1 ( 10.0%) 0 0 0 0
MYALGIA 筋肉痛 0 0 0 1 ( 10.0%) 0
PAIN IN EXTREMITY 四肢痛 0 1 ( 10.0%) 0 0 0
NERVOUS SYSTEM DISORDERS 神経系障害 0 0 2 ( 18.2%) 0 2 ( 20.0%)
DIZZINESS 浮動性めまい 0 0 0 0 2 ( 20.0%)
8 MG TAF
(N=10) 25 MG TAF
QD (N=10) 40 MG TAF
QD (N=11) 120 MG TAF
QD (N=10) 300 MG TDF QD (N=10)
HEADACHE 頭痛 0 0 1 ( 9.1%) 0 1 ( 10.0%)
DYSGEUSIA 味覚異常 0 0 0 0 1 ( 10.0%)
LETHARGY 嗜眠 0 0 1 ( 9.1%) 0 0
SOMNOLENCE 傾眠 0 0 1 ( 9.1%) 0 0
PSYCHIATRIC DISORDERS 精神障害 1 ( 10.0%) 0 0 1 ( 10.0%) 0
LOSS OF LIBIDO リビド消失 1 ( 10.0%) 0 0 0 0
SLEEP DISORDER 睡眠障害 0 0 0 1 ( 10.0%) 0
RENAL AND URINARY DISORDERS 腎および尿路障害 0 0 0 0 1 ( 10.0%)
POLYURIA 多尿 0 0 0 0 1 ( 10.0%)
RESPIRATORY, THORACIC AND MEDIASTINAL
DISORDERS 呼吸器、胸郭および縦隔障害
0 1 ( 10.0%) 0 0 2 ( 20.0%)
RHINORRHOEA 鼻漏 0 1 ( 10.0%) 0 0 1 ( 10.0%)
OROPHARYNGEAL PAIN 口腔咽頭痛 0 0 0 0 1 ( 10.0%)
Data Extracted: 21AUG2013
Source: /u/gs7340/adhoc/req7941/prog/r-req7941-t-teae-3200101.sas v9.2 Output file: t-teae-rel-s3200101.out 24FEB2016:13:10
死亡及び重篤な有害事象発現例の叙述 26.6.2
本試験中に死亡例及び重篤な有害事象は報告されなかった。