2.7.6 個々の試験のまとめ
2.7.6.6 付録
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 122
表 2.7.6.6-1 有害事象発現例数（JV19595，SAFETY）
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
ALL BODY SYSTEMS
Total Pts with at Least one AE 63 (100.0) 61 (100.0) 29 ( 87.9) Total Number of AEs 1476 1297 179 臨床検査
Total Pts With at Least one AE 63 (100.0) 61 (100.0) 15 ( 45.5) 好中球数減少 61 ( 96.8) 58 ( 95.1) 3 ( 9.1) 白血球数減少 57 ( 90.5) 54 ( 88.5) 1 ( 3.0) ヘモグロビン減少 54 ( 85.7) 47 ( 77.0) - 赤血球数減少 53 ( 84.1) 48 ( 78.7) - 血小板数減少 50 ( 79.4) 48 ( 78.7) - ヘマトクリット減少 43 ( 68.3) 37 ( 60.7) - リンパ球数減少 38 ( 60.3) 28 ( 45.9) 1 ( 3.0) アラニン・アミノトランスフェラ 26 ( 41.3) 13 ( 21.3) 3 ( 9.1) ーゼ増加
アスパラギン酸アミノトランスフ 26 ( 41.3) 12 ( 19.7) 1 ( 3.0) ェラーゼ増加
γ－グルタミルトランスフェラー 22 ( 34.9) 15 ( 24.6) 1 ( 3.0) ゼ増加
血中リン減少 12 ( 19.0) 13 ( 21.3) 3 ( 9.1) 血中非抱合ビリルビン増加 9 ( 14.3) 7 ( 11.5) - 血中トリグリセリド増加 10 ( 15.9) 3 ( 4.9) 2 ( 6.1) 体重減少 13 ( 20.6) 2 ( 3.3) - 抱合ビリルビン増加 7 ( 11.1) 7 ( 11.5) - 血中カルシウム減少 4 ( 6.3) 6 ( 9.8) - Ｃ－反応性蛋白増加 5 ( 7.9) 2 ( 3.3) 2 ( 6.1) 血中ビリルビン増加 4 ( 6.3) 5 ( 8.2) - 心拍数増加 5 ( 7.9) 3 ( 4.9) - 尿中ブドウ糖陽性 1 ( 1.6) 3 ( 4.9) 3 ( 9.1) 尿中蛋白陽性 2 ( 3.2) 4 ( 6.6) 1 ( 3.0) 血圧上昇 - 2 ( 3.3) 4 ( 12.1) 血中アルカリホスファターゼ増加 3 ( 4.8) 2 ( 3.3) 1 ( 3.0) 血中ブドウ糖増加 1 ( 1.6) 5 ( 8.2) - 総蛋白増加 4 ( 6.3) 2 ( 3.3) - 遊離トリヨードチロニン減少 4 ( 6.3) 1 ( 1.6) 1 ( 3.0) 血中甲状腺刺激ホルモン増加 3 ( 4.8) 2 ( 3.3) - 尿中血陽性 1 ( 1.6) 2 ( 3.3) 1 ( 3.0) 血中尿酸増加 1 ( 1.6) 2 ( 3.3) - ビタミンＫ欠乏時産生蛋白ＩＩ上 1 ( 1.6) - 1 ( 3.0) 昇
α１フェトプロテイン増加 1 ( 1.6) - 1 ( 3.0) 血中アルブミン減少 - 1 ( 1.6) 1 ( 3.0) 細胞マーカー増加 1 ( 1.6) - 1 ( 3.0) プロトロンビン量減少 - 1 ( 1.6) - 拡張期血圧上昇 - 1 ( 1.6) - 眼圧上昇 1 ( 1.6) - - 血圧低下 - 1 ( 1.6) - 血中甲状腺刺激ホルモン減少 1 ( 1.6) - - 血中乳酸脱水素酵素増加 1 ( 1.6) - - 血中尿素増加 - 1 ( 1.6) - 呼吸数増加 1 ( 1.6) - - 好塩基球数増加 1 ( 1.6) - - 好酸球数減少 1 ( 1.6) - - 好中球数増加 1 ( 1.6) - - 収縮期血圧低下 1 ( 1.6) - - 心雑音 - 1 ( 1.6) - 心電図ＱＴ補正間隔延長 - 1 ( 1.6) - 心電図Ｔ波振幅減少 - 1 ( 1.6) - 心拍数減少 - - 1 ( 3.0) 潜血陽性 1 ( 1.6) - - 体重増加 - 1 ( 1.6) - 単球数減少 1 ( 1.6) - - 尿比重増加 1 ( 1.6) - - 尿量減少 1 ( 1.6) - - (body system continuing ...)
___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (1 of 10)
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 123
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
(... body system continuing)
脳性ナトリウム利尿ペプチド上昇 - 1 ( 1.6) - 白血球数増加 1 ( 1.6) - - 皮膚テスト陽性 1 ( 1.6) - - 遊離トリヨードチロニン増加 - - 1 ( 3.0) Total Number of AEs 536 443 34 全身障害および投与局所様態
Total Pts With at Least one AE 62 ( 98.4) 57 ( 93.4) 13 ( 39.4) 発熱 61 ( 96.8) 48 ( 78.7) 7 ( 21.2) 倦怠感 47 ( 74.6) 45 ( 73.8) 7 ( 21.2) 熱感 17 ( 27.0) 9 ( 14.8) - 注射部位そう痒感 14 ( 22.2) 11 ( 18.0) - 注射部位紅斑 14 ( 22.2) 7 ( 11.5) - 悪寒 11 ( 17.5) 3 ( 4.9) 3 ( 9.1) 口渇 5 ( 7.9) 6 ( 9.8) 1 ( 3.0) 末梢性浮腫 3 ( 4.8) 6 ( 9.8) 1 ( 3.0) 注射部位内出血 6 ( 9.5) 3 ( 4.9) - 疲労 1 ( 1.6) 5 ( 8.2) 1 ( 3.0) 易刺激性 3 ( 4.8) 3 ( 4.9) - 注射部位発疹 4 ( 6.3) 2 ( 3.3) - 異常感 3 ( 4.8) 2 ( 3.3) - 胸痛 3 ( 4.8) 1 ( 1.6) - 胸部不快感 - 4 ( 6.6) - 冷感 3 ( 4.8) 1 ( 1.6) - 無力症 - 3 ( 4.9) - 局所腫脹 1 ( 1.6) 1 ( 1.6) - 穿刺部位疼痛 2 ( 3.2) - - 注射部位出血 1 ( 1.6) 1 ( 1.6) - 注射部位熱感 2 ( 3.2) - - 注射部位変色 1 ( 1.6) 1 ( 1.6) - 注射部位疼痛 - 2 ( 3.3) - 顔面痛 - 1 ( 1.6) - 血管穿刺部位内出血 1 ( 1.6) - - 血管穿刺部位反応 1 ( 1.6) - - 腫瘤 - 1 ( 1.6) - 注射部位腫脹 1 ( 1.6) - - 注射部位反応 - 1 ( 1.6) - Total Number of AEs 205 167 20 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (2 of 10)
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2.7.6
個々の試験のまとめPage 124
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
皮膚および皮下組織障害
Total Pts With at Least one AE 54 ( 85.7) 49 ( 80.3) 7 ( 21.2) そう痒症 30 ( 47.6) 28 ( 45.9) 1 ( 3.0) 発疹 19 ( 30.2) 21 ( 34.4) 3 ( 9.1) 脱毛症 14 ( 22.2) 15 ( 24.6) - 全身性そう痒症 12 ( 19.0) 15 ( 24.6) 1 ( 3.0) 紅斑 11 ( 17.5) 12 ( 19.7) 1 ( 3.0) 湿疹 5 ( 7.9) 11 ( 18.0) 1 ( 3.0) 皮膚乾燥 6 ( 9.5) 3 ( 4.9) - 貨幣状湿疹 3 ( 4.8) 3 ( 4.9) - 皮下出血 5 ( 7.9) 1 ( 1.6) - 皮脂欠乏性湿疹 4 ( 6.3) 2 ( 3.3) - 全身性皮疹 1 ( 1.6) 3 ( 4.9) 1 ( 3.0) 脂漏性皮膚炎 3 ( 4.8) 1 ( 1.6) - 色素沈着障害 2 ( 3.2) 2 ( 3.3) - 接触性皮膚炎 1 ( 1.6) 2 ( 3.3) 1 ( 3.0) 全身紅斑 - 3 ( 4.9) - 多汗症 2 ( 3.2) 1 ( 1.6) - 過角化 1 ( 1.6) 1 ( 1.6) - 水疱 1 ( 1.6) 1 ( 1.6) - 皮膚炎 2 ( 3.2) - - 薬疹 1 ( 1.6) 1 ( 1.6) - 冷汗 2 ( 3.2) - - 痒疹 2 ( 3.2) - - さじ状爪 1 ( 1.6) - - そう痒性皮疹 1 ( 1.6) - - 円形脱毛症 - 1 ( 1.6) - 紅色汗疹 1 ( 1.6) - - 紅斑性皮疹 - 1 ( 1.6) - 紫斑 - 1 ( 1.6) - 脂肪織炎 - 1 ( 1.6) - 尋常性白斑 - - 1 ( 3.0) 多形紅斑 1 ( 1.6) - - 中毒性皮疹 1 ( 1.6) - - 皮膚びらん - - 1 ( 3.0) 皮膚潰瘍 1 ( 1.6) - - 皮膚熱感 1 ( 1.6) - - 瘢痕 - - 1 ( 3.0) 瘢痕痛 - - 1 ( 3.0) 蕁麻疹 1 ( 1.6) - - Total Number of AEs 135 130 13 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ペガシス／コペガス
2.7.6
個々の試験のまとめPage 125
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
胃腸障害
Total Pts With at Least one AE 48 ( 76.2) 45 ( 73.8) 14 ( 42.4) 悪心 16 ( 25.4) 14 ( 23.0) 3 ( 9.1) 下痢 11 ( 17.5) 12 ( 19.7) 5 ( 15.2) 便秘 9 ( 14.3) 16 ( 26.2) 2 ( 6.1) 口内炎 13 ( 20.6) 9 ( 14.8) - 胃不快感 11 ( 17.5) 8 ( 13.1) 2 ( 6.1) 嘔吐 6 ( 9.5) 5 ( 8.2) 1 ( 3.0) 上腹部痛 5 ( 7.9) 2 ( 3.3) 2 ( 6.1) 腹痛 4 ( 6.3) 3 ( 4.9) 1 ( 3.0) 腹部不快感 4 ( 6.3) 4 ( 6.6) - 口唇炎 7 ( 11.1) - - 腹部膨満 3 ( 4.8) 2 ( 3.3) 2 ( 6.1) 歯肉炎 5 ( 7.9) 1 ( 1.6) - 歯肉出血 1 ( 1.6) 5 ( 8.2) - 歯痛 3 ( 4.8) 2 ( 3.3) - 消化不良 3 ( 4.8) 2 ( 3.3) - 腹水 2 ( 3.2) 1 ( 1.6) 2 ( 6.1) 下腹部痛 3 ( 4.8) - 1 ( 3.0) 歯周炎 3 ( 4.8) 1 ( 1.6) - 歯肉腫脹 3 ( 4.8) 1 ( 1.6) - 歯肉痛 3 ( 4.8) 1 ( 1.6) - 胃炎 1 ( 1.6) 1 ( 1.6) 1 ( 3.0) 逆流性食道炎 - 1 ( 1.6) 1 ( 3.0) 血便排泄 2 ( 3.2) - - 口腔内不快感 - 2 ( 3.3) - 口腔扁平苔癬 1 ( 1.6) 1 ( 1.6) - 痔核 2 ( 3.2) - - 心窩部不快感 1 ( 1.6) 1 ( 1.6) - 排便障害 - 2 ( 3.3) - 変色便 1 ( 1.6) 1 ( 1.6) - 齲歯 2 ( 3.2) - - 胃出血 - 1 ( 1.6) - 胃静脈瘤 1 ( 1.6) - - 胃潰瘍 - 1 ( 1.6) - 過敏性腸症候群 1 ( 1.6) - - 結腸ポリープ 1 ( 1.6) - - 口の錯感覚 - 1 ( 1.6) - 口腔内出血 1 ( 1.6) - - 口腔内痛 1 ( 1.6) - - 口腔内白斑症 - 1 ( 1.6) - 口腔粘膜びらん 1 ( 1.6) - - 口唇のひび割れ - 1 ( 1.6) - 口唇びらん 1 ( 1.6) - - 口唇腫脹 1 ( 1.6) - - 歯周病 1 ( 1.6) - - 耳下腺腫大 - - 1 ( 3.0) 小腸出血 - 1 ( 1.6) - 食中毒 - - 1 ( 3.0) 食道静脈瘤出血 1 ( 1.6) - - 舌炎 - 1 ( 1.6) - 舌痛 - 1 ( 1.6) - 腸炎 1 ( 1.6) - - 吐血 - 1 ( 1.6) - 排便回数増加 - 1 ( 1.6) - 不正咬合 - 1 ( 1.6) - 裂孔ヘルニア - - 1 ( 3.0) 肛門潰瘍 - 1 ( 1.6) - 鼡径ヘルニア 1 ( 1.6) - - Total Number of AEs 137 110 26 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (4 of 10)
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 126
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
筋骨格系および結合組織障害
Total Pts With at Least one AE 44 ( 69.8) 41 ( 67.2) 9 ( 27.3) 関節痛 23 ( 36.5) 23 ( 37.7) 2 ( 6.1) 背部痛 16 ( 25.4) 11 ( 18.0) 3 ( 9.1) 筋痛 10 ( 15.9) 10 ( 16.4) 1 ( 3.0) 四肢痛 7 ( 11.1) 10 ( 16.4) 2 ( 6.1) 筋痙縮 5 ( 7.9) 4 ( 6.6) 3 ( 9.1) 筋骨格痛 2 ( 3.2) 7 ( 11.5) - 筋骨格硬直 1 ( 1.6) 6 ( 9.8) - 骨関節炎 1 ( 1.6) 3 ( 4.9) - 頚部痛 1 ( 1.6) 2 ( 3.3) - 変形性脊椎炎 2 ( 3.2) 1 ( 1.6) - 側腹部痛 1 ( 1.6) - 1 ( 3.0) 鼡径部痛 2 ( 3.2) - - 関節腫脹 - 1 ( 1.6) - 関節周囲炎 1 ( 1.6) - - 筋緊張 - 1 ( 1.6) - 筋力低下 1 ( 1.6) - - 肩回旋筋腱板症候群 - 1 ( 1.6) - 項部硬直 1 ( 1.6) - - 脊椎靱帯骨化症 1 ( 1.6) - - 仙腸骨炎 1 ( 1.6) - - 多発性関節炎 - 1 ( 1.6) - Total Number of AEs 76 81 12 呼吸器、胸郭および縦隔障害
Total Pts With at Least one AE 41 ( 65.1) 40 ( 65.6) 10 ( 30.3) 咳嗽 24 ( 38.1) 21 ( 34.4) 5 ( 15.2) 咽喉頭疼痛 12 ( 19.0) 16 ( 26.2) 4 ( 12.1) 鼻出血 11 ( 17.5) 14 ( 23.0) 1 ( 3.0) 鼻漏 5 ( 7.9) 7 ( 11.5) 4 ( 12.1) 湿性咳嗽 8 ( 12.7) 4 ( 6.6) 1 ( 3.0) 呼吸困難 5 ( 7.9) 5 ( 8.2) - 咽頭紅斑 1 ( 1.6) 3 ( 4.9) 1 ( 3.0) 鼻閉 4 ( 6.3) 1 ( 1.6) - 咽喉頭不快感 1 ( 1.6) 3 ( 4.9) - くしゃみ 1 ( 1.6) 1 ( 1.6) 1 ( 3.0) アレルギー性鼻炎 - 2 ( 3.3) - 間質性肺疾患 1 ( 1.6) 1 ( 1.6) - 発声障害 2 ( 3.2) - - 喀血 1 ( 1.6) - 1 ( 3.0) 血管運動性鼻炎 - 1 ( 1.6) - 睡眠時無呼吸症候群 - - 1 ( 3.0) 声帯萎縮 - 1 ( 1.6) - 低酸素症 1 ( 1.6) - - 鼻潰瘍 1 ( 1.6) - - 鼻嚢胞 1 ( 1.6) - - 無気肺 - - 1 ( 3.0) 労作性呼吸困難 - 1 ( 1.6) - 扁桃肥大 - 1 ( 1.6) - Total Number of AEs 79 82 20 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (5 of 10)
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 127
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
感染症および寄生虫症
Total Pts With at Least one AE 41 ( 65.1) 31 ( 50.8) 14 ( 42.4) 鼻咽頭炎 25 ( 39.7) 22 ( 36.1) 10 ( 30.3) 上気道感染 3 ( 4.8) 4 ( 6.6) 2 ( 6.1) 麦粒腫 2 ( 3.2) 4 ( 6.6) - 膀胱炎 4 ( 6.3) 1 ( 1.6) 1 ( 3.0) 毛包炎 1 ( 1.6) 4 ( 6.6) - 外耳炎 1 ( 1.6) 2 ( 3.3) - 尿路感染 2 ( 3.2) 1 ( 1.6) - 咽頭炎 2 ( 3.2) - - 気管支炎 - 2 ( 3.3) - 急性気管支炎 - 2 ( 3.3) - 股部白癬 1 ( 1.6) 1 ( 1.6) - 歯髄炎 2 ( 3.2) - - 足部白癬 - 2 ( 3.3) - 爪白癬 2 ( 3.2) - - 白癬感染 1 ( 1.6) 1 ( 1.6) - 鼻炎 1 ( 1.6) 1 ( 1.6) - 蜂巣炎 2 ( 3.2) - - ウイルス性上気道感染 1 ( 1.6) - - ウイルス性腸炎 1 ( 1.6) - - ヘリコバクター感染 1 ( 1.6) - - 感染性腸炎 1 ( 1.6) - - 感染性表皮嚢胞 - - 1 ( 3.0) 口腔カンジダ症 1 ( 1.6) - - 腰筋膿瘍 1 ( 1.6) - - 帯状疱疹 1 ( 1.6) - - 単純ヘルペス - - 1 ( 3.0) 肺炎 - - 1 ( 3.0) 扁桃炎 - 1 ( 1.6) - 腟感染 1 ( 1.6) - - Total Number of AEs 57 48 16 神経系障害
Total Pts With at Least one AE 41 ( 65.1) 35 ( 57.4) 2 ( 6.1) 頭痛 31 ( 49.2) 28 ( 45.9) 2 ( 6.1) 浮動性めまい 6 ( 9.5) 12 ( 19.7) - 味覚異常 7 ( 11.1) 4 ( 6.6) - 感覚鈍麻 5 ( 7.9) 4 ( 6.6) 1 ( 3.0) 体位性めまい 2 ( 3.2) 5 ( 8.2) - 振戦 1 ( 1.6) 3 ( 4.9) - 嗅覚錯誤 2 ( 3.2) 2 ( 3.3) - 末梢性ニューロパシー 2 ( 3.2) 1 ( 1.6) - 傾眠 - 2 ( 3.3) - 知覚過敏 - 2 ( 3.3) - 意識消失 - 1 ( 1.6) - 感覚障害 - 1 ( 1.6) - 顔面神経麻痺 - - 1 ( 3.0) 顔面部神経痛 - - 1 ( 3.0) 記憶障害 - 1 ( 1.6) - 血管迷走神経性失神 - 1 ( 1.6) - 錯感覚 1 ( 1.6) - - 手根管症候群 1 ( 1.6) - - 注意力障害 - 1 ( 1.6) - 頭部不快感 1 ( 1.6) - - 味覚減退 1 ( 1.6) - - Total Number of AEs 60 68 5 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (6 of 10)
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 128
ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
眼障害
Total Pts With at Least one AE 33 ( 52.4) 30 ( 49.2) 3 ( 9.1) 網膜出血 12 ( 19.0) 7 ( 11.5) - 網膜滲出物 7 ( 11.1) 6 ( 9.8) - 網膜症 7 ( 11.1) 5 ( 8.2) - 白内障 2 ( 3.2) 2 ( 3.3) 1 ( 3.0) アレルギー性結膜炎 1 ( 1.6) 3 ( 4.9) - 眼乾燥 1 ( 1.6) 2 ( 3.3) 1 ( 3.0) 結膜炎 2 ( 3.2) 2 ( 3.3) - 眼そう痒症 3 ( 4.8) - - 眼痛 1 ( 1.6) 2 ( 3.3) - 眼瞼炎 2 ( 3.2) 1 ( 1.6) - 結膜出血 2 ( 3.2) 1 ( 1.6) - 眼の異常感 1 ( 1.6) 1 ( 1.6) - 眼出血 - 2 ( 3.3) - 眼精疲労 1 ( 1.6) - 1 ( 3.0) 結膜充血 2 ( 3.2) - - 光視症 1 ( 1.6) 1 ( 1.6) - 硝子体浮遊物 2 ( 3.2) - - 霧視 1 ( 1.6) 1 ( 1.6) - 網膜裂孔 1 ( 1.6) 1 ( 1.6) - 緑内障 - 2 ( 3.3) - 黄斑症 - 1 ( 1.6) - 黄斑浮腫 1 ( 1.6) - - 角膜浮腫 1 ( 1.6) - - 眼の異物感 1 ( 1.6) - - 眼脂 1 ( 1.6) - - 眼充血 1 ( 1.6) - - 後嚢部混濁 - - 1 ( 3.0) 高血圧性網膜症 - - 1 ( 3.0) 視力低下 1 ( 1.6) - - 星状硝子体症 - 1 ( 1.6) - 点状角膜炎 1 ( 1.6) - - 網膜静脈閉塞 1 ( 1.6) - - 網膜変性 - 1 ( 1.6) - 羞明 1 ( 1.6) - - 霰粒腫 - 1 ( 1.6) - Total Number of AEs 58 43 5 精神障害
Total Pts With at Least one AE 19 ( 30.2) 30 ( 49.2) 3 ( 9.1) 不眠症 18 ( 28.6) 25 ( 41.0) 1 ( 3.0) 不安 2 ( 3.2) 1 ( 1.6) 1 ( 3.0) 失見当識 - 2 ( 3.3) - 抑うつ症状 1 ( 1.6) 1 ( 1.6) - うつ病 - 1 ( 1.6) - 異常行動 - 1 ( 1.6) - 幻視 - 1 ( 1.6) - 初期不眠症 - - 1 ( 3.0) 中期不眠症 1 ( 1.6) - - 不安障害 - 1 ( 1.6) - 落ち着きのなさ - 1 ( 1.6) - 譫妄 - 1 ( 1.6) - Total Number of AEs 22 35 3 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
代謝および栄養障害
Total Pts With at Least one AE 23 ( 36.5) 19 ( 31.1) 2 ( 6.1) 食欲不振 14 ( 22.2) 12 ( 19.7) 1 ( 3.0) 食欲減退 8 ( 12.7) 6 ( 9.8) - 糖尿病 1 ( 1.6) 3 ( 4.9) 1 ( 3.0) インスリン非依存性糖尿病 - 1 ( 1.6) - 高尿酸血症 1 ( 1.6) - - 脱水 1 ( 1.6) - - 痛風 1 ( 1.6) - - 低血糖症 1 ( 1.6) - - Total Number of AEs 27 22 2 傷害、中毒および処置合併症
Total Pts With at Least one AE 18 ( 28.6) 11 ( 18.0) 2 ( 6.1) 挫傷 3 ( 4.8) 1 ( 1.6) - 背部損傷 2 ( 3.2) 1 ( 1.6) 1 ( 3.0) むち打ち損傷 1 ( 1.6) 1 ( 1.6) - 頚部損傷 2 ( 3.2) - - 擦過傷 2 ( 3.2) - - 処置による疼痛 - 2 ( 3.3) - 節足動物刺傷 2 ( 3.2) - - 創合併症 - 2 ( 3.3) - 創傷 2 ( 3.2) - - 足骨折 1 ( 1.6) 1 ( 1.6) - 転倒 1 ( 1.6) 1 ( 1.6) - 一酸化炭素中毒 1 ( 1.6) - - 関節捻挫 - 1 ( 1.6) - 眼外傷 1 ( 1.6) - - 眼内異物 - 1 ( 1.6) - 口腔内損傷 - 1 ( 1.6) - 術後創合併症 1 ( 1.6) - - 術後発熱 - 1 ( 1.6) - 処置後めまい 1 ( 1.6) - - 処置後悪心 - 1 ( 1.6) - 処置後嘔吐 - 1 ( 1.6) - 脊椎圧迫骨折 1 ( 1.6) - - 舌損傷 - - 1 ( 3.0) 熱射病 1 ( 1.6) - - 皮下血腫 1 ( 1.6) - - 橈骨骨折 - 1 ( 1.6) - Total Number of AEs 23 16 2 良性、悪性および詳細不明の新生物
（嚢胞およびポリープを含む）
Total Pts With at Least one AE 13 ( 20.6) 9 ( 14.8) 5 ( 15.2) 肝の悪性新生物 7 ( 11.1) 7 ( 11.5) 3 ( 9.1) 脂漏性角化症 1 ( 1.6) 1 ( 1.6) - 肝臓血管腫 - 1 ( 1.6) - 癌性リンパ管症 - - 1 ( 3.0) 癌疼痛 - - 1 ( 3.0) 基底細胞癌 1 ( 1.6) - - 限局性結節性過形成 - - 1 ( 3.0) 黒子 1 ( 1.6) - - 骨転移 - - 1 ( 3.0) 再発肝臓悪性新生物 - - 1 ( 3.0) 成人Ｔ細胞リンパ腫・白血病 1 ( 1.6) - - 前立腺癌 1 ( 1.6) - - 肺の悪性新生物 - - 1 ( 3.0) 皮膚乳頭腫 1 ( 1.6) - - 副腎転移 - - 1 ( 3.0) Total Number of AEs 13 9 10 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
腎および尿路障害
Total Pts With at Least one AE 9 ( 14.3) 7 ( 11.5) 3 ( 9.1) 頻尿 6 ( 9.5) 1 ( 1.6) - 血尿 1 ( 1.6) - 2 ( 6.1) 排尿困難 1 ( 1.6) 2 ( 3.3) - 夜間頻尿 1 ( 1.6) 2 ( 3.3) - 尿管結石 1 ( 1.6) 1 ( 1.6) - 尿閉 1 ( 1.6) 1 ( 1.6) - 緊張性膀胱 1 ( 1.6) - - 神経因性膀胱 1 ( 1.6) - - 腎石灰沈着症 - - 1 ( 3.0) 腎嚢胞 - 1 ( 1.6) - 尿意切迫 1 ( 1.6) - - 尿失禁 1 ( 1.6) - - 膀胱炎様症状 1 ( 1.6) - - Total Number of AEs 16 8 3 血液およびリンパ系障害
Total Pts With at Least one AE 6 ( 9.5) 4 ( 6.6) 3 ( 9.1) 貧血 5 ( 7.9) 3 ( 4.9) 2 ( 6.1) リンパ節症 1 ( 1.6) - 1 ( 3.0) リンパ節炎 - 1 ( 1.6) - リンパ節痛 1 ( 1.6) - - Total Number of AEs 7 4 3 耳および迷路障害
Total Pts With at Least one AE 4 ( 6.3) 6 ( 9.8) 2 ( 6.1) 回転性めまい 2 ( 3.2) 3 ( 4.9) 1 ( 3.0) 耳鳴 1 ( 1.6) 3 ( 4.9) 1 ( 3.0) メニエール病 - 1 ( 1.6) - 耳不快感 1 ( 1.6) - - 耳漏 - 1 ( 1.6) - 聴覚不全 1 ( 1.6) - - 聴力低下 - 1 ( 1.6) - 難聴 - 1 ( 1.6) - 片耳難聴 1 ( 1.6) - - Total Number of AEs 6 10 2 心臓障害
Total Pts With at Least one AE 5 ( 7.9) 3 ( 4.9) 1 ( 3.0) 動悸 5 ( 7.9) 2 ( 3.3) - 右脚ブロック - 1 ( 1.6) - 三尖弁閉鎖不全症 - 1 ( 1.6) - 徐脈 - 1 ( 1.6) - 上室性期外収縮 - - 1 ( 3.0) 心室性期外収縮 - 1 ( 1.6) - 洞性頻脈 1 ( 1.6) - - Total Number of AEs 6 6 1 生殖系および乳房障害
Total Pts With at Least one AE 3 ( 4.8) 5 ( 8.2) 1 ( 3.0) 良性前立腺肥大症 1 ( 1.6) 3 ( 4.9) - 陰嚢血瘤 - 1 ( 1.6) - 外陰部出血 - 1 ( 1.6) - 月経過多 1 ( 1.6) - - 女性化乳房 1 ( 1.6) - - 男性陰部そう痒症 - - 1 ( 3.0) 乳房腫脹 1 ( 1.6) - - Total Number of AEs 4 5 1 ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11aesum_sppa Summary of Adverse Events by Body System and Trial Treatment Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
___________________________________________________________________________________
Body System/ PEG-IFN PEG-IFN Observation Adverse Event 180 mcg 90 mcg Group + RBV + RBV
N = 63 N = 61 N = 33 No. (%) No. (%) No. (%) ___________________________________________________________________________________
血管障害
Total Pts With at Least one AE 4 ( 6.3) 5 ( 8.2) - 高血圧 1 ( 1.6) 3 ( 4.9) - 静脈瘤 1 ( 1.6) 1 ( 1.6) - ほてり - 1 ( 1.6) - リンパ浮腫 1 ( 1.6) - - 低血圧 1 ( 1.6) - - Total Number of AEs 4 5 - 肝胆道系障害
Total Pts With at Least one AE 3 ( 4.8) 3 ( 4.9) 1 ( 3.0) 脂肪肝 2 ( 3.2) 1 ( 1.6) - 胆石症 - 1 ( 1.6) 1 ( 3.0) 過形成性胆嚢症 - 1 ( 1.6) - 肝石灰化 - 1 ( 1.6) - 胆嚢ポリープ 1 ( 1.6) - - Total Number of AEs 3 4 1 内分泌障害
Total Pts With at Least one AE 1 ( 1.6) 1 ( 1.6) - バセドウ病 1 ( 1.6) - - 甲状腺機能低下症 1 ( 1.6) - - 自己免疫性甲状腺炎 - 1 ( 1.6) - Total Number of AEs 2 1 - ___________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:26:08 (10 of 10)
［
5.3.5.1-1
表12.2.3.1-1
の再掲］ペガシス／コペガス
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表 2.7.6.6-2 因果関係が否定できない有害事象の発現例数（JV19595，SAFETY）
ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
ALL BODY SYSTEMS
Total Pts with at Least one AE 63 (100.0) 61 (100.0) Total Number of AEs 1217 1103 臨床検査
Total Pts With at Least one AE 63 (100.0) 61 (100.0) 好中球数減少 61 ( 96.8) 58 ( 95.1) 白血球数減少 57 ( 90.5) 54 ( 88.5) ヘモグロビン減少 54 ( 85.7) 47 ( 77.0) 赤血球数減少 53 ( 84.1) 48 ( 78.7) 血小板数減少 49 ( 77.8) 48 ( 78.7) ヘマトクリット減少 43 ( 68.3) 37 ( 60.7) リンパ球数減少 38 ( 60.3) 27 ( 44.3) γ－グルタミルトランスフェラー 22 ( 34.9) 11 ( 18.0) ゼ増加
アスパラギン酸アミノトランスフ 23 ( 36.5) 8 ( 13.1) ェラーゼ増加
アラニン・アミノトランスフェラ 22 ( 34.9) 8 ( 13.1) ーゼ増加
血中リン減少 11 ( 17.5) 11 ( 18.0) 体重減少 13 ( 20.6) 2 ( 3.3) 血中非抱合ビリルビン増加 7 ( 11.1) 7 ( 11.5) 抱合ビリルビン増加 7 ( 11.1) 7 ( 11.5) 血中トリグリセリド増加 9 ( 14.3) 3 ( 4.9) 血中カルシウム減少 4 ( 6.3) 6 ( 9.8) 血中ビリルビン増加 3 ( 4.8) 5 ( 8.2) 血中甲状腺刺激ホルモン増加 3 ( 4.8) 2 ( 3.3) 心拍数増加 3 ( 4.8) 2 ( 3.3) 総蛋白増加 4 ( 6.3) 1 ( 1.6) 尿中蛋白陽性 2 ( 3.2) 3 ( 4.9) 遊離トリヨードチロニン減少 4 ( 6.3) 1 ( 1.6) 血中アルカリホスファターゼ増加 2 ( 3.2) 2 ( 3.3) 血中ブドウ糖増加 - 4 ( 6.6) 尿中ブドウ糖陽性 1 ( 1.6) 3 ( 4.9) Ｃ－反応性蛋白増加 1 ( 1.6) 2 ( 3.3) 血中尿酸増加 1 ( 1.6) 2 ( 3.3) 血圧上昇 - 2 ( 3.3) 尿中血陽性 1 ( 1.6) 1 ( 1.6) プロトロンビン量減少 - 1 ( 1.6) 眼圧上昇 1 ( 1.6) - 血圧低下 - 1 ( 1.6) 血中甲状腺刺激ホルモン減少 1 ( 1.6) - 血中尿素増加 - 1 ( 1.6) 好塩基球数増加 1 ( 1.6) - 好酸球数減少 1 ( 1.6) - 細胞マーカー増加 1 ( 1.6) - 心雑音 - 1 ( 1.6) 心電図ＱＴ補正間隔延長 - 1 ( 1.6) 心電図Ｔ波振幅減少 - 1 ( 1.6) 体重増加 - 1 ( 1.6) 単球数減少 1 ( 1.6) - 脳性ナトリウム利尿ペプチド上昇 - 1 ( 1.6) Total Number of AEs 504 420 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
全身障害および投与局所様態
Total Pts With at Least one AE 62 ( 98.4) 56 ( 91.8) 発熱 58 ( 92.1) 41 ( 67.2) 倦怠感 46 ( 73.0) 45 ( 73.8) 注射部位そう痒感 14 ( 22.2) 10 ( 16.4) 熱感 15 ( 23.8) 9 ( 14.8) 注射部位紅斑 14 ( 22.2) 7 ( 11.5) 悪寒 10 ( 15.9) 3 ( 4.9) 口渇 3 ( 4.8) 5 ( 8.2) 易刺激性 3 ( 4.8) 3 ( 4.9) 注射部位内出血 3 ( 4.8) 3 ( 4.9) 注射部位発疹 4 ( 6.3) 2 ( 3.3) 疲労 1 ( 1.6) 4 ( 6.6) 末梢性浮腫 1 ( 1.6) 4 ( 6.6) 異常感 2 ( 3.2) 2 ( 3.3) 胸部不快感 - 4 ( 6.6) 冷感 2 ( 3.2) 1 ( 1.6) 胸痛 1 ( 1.6) 1 ( 1.6) 注射部位出血 1 ( 1.6) 1 ( 1.6) 注射部位熱感 2 ( 3.2) - 注射部位変色 1 ( 1.6) 1 ( 1.6) 注射部位疼痛 - 2 ( 3.3) 無力症 - 2 ( 3.3) 局所腫脹 - 1 ( 1.6) 注射部位腫脹 1 ( 1.6) - 注射部位反応 - 1 ( 1.6) Total Number of AEs 182 152 皮膚および皮下組織障害
Total Pts With at Least one AE 52 ( 82.5) 49 ( 80.3) そう痒症 26 ( 41.3) 27 ( 44.3) 発疹 18 ( 28.6) 20 ( 32.8) 脱毛症 14 ( 22.2) 15 ( 24.6) 全身性そう痒症 12 ( 19.0) 14 ( 23.0) 紅斑 9 ( 14.3) 10 ( 16.4) 湿疹 5 ( 7.9) 11 ( 18.0) 皮膚乾燥 5 ( 7.9) 2 ( 3.3) 皮下出血 5 ( 7.9) - 皮脂欠乏性湿疹 4 ( 6.3) 1 ( 1.6) 貨幣状湿疹 1 ( 1.6) 3 ( 4.9) 脂漏性皮膚炎 2 ( 3.2) 1 ( 1.6) 色素沈着障害 2 ( 3.2) 1 ( 1.6) 全身紅斑 - 3 ( 4.9) 全身性皮疹 1 ( 1.6) 2 ( 3.3) 多汗症 2 ( 3.2) 1 ( 1.6) 皮膚炎 2 ( 3.2) - 薬疹 1 ( 1.6) 1 ( 1.6) 冷汗 2 ( 3.2) - 痒疹 2 ( 3.2) - さじ状爪 1 ( 1.6) - そう痒性皮疹 1 ( 1.6) - 過角化 1 ( 1.6) - 紅斑性皮疹 - 1 ( 1.6) 紫斑 - 1 ( 1.6) 脂肪織炎 - 1 ( 1.6) 水疱 1 ( 1.6) - 接触性皮膚炎 - 1 ( 1.6) 多形紅斑 1 ( 1.6) - 中毒性皮疹 1 ( 1.6) - 皮膚潰瘍 1 ( 1.6) - 皮膚熱感 1 ( 1.6) - 蕁麻疹 1 ( 1.6) - Total Number of AEs 122 116 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:29:25 (2 of 8)
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
胃腸障害
Total Pts With at Least one AE 45 ( 71.4) 41 ( 67.2) 悪心 13 ( 20.6) 10 ( 16.4) 口内炎 11 ( 17.5) 9 ( 14.8) 胃不快感 10 ( 15.9) 8 ( 13.1) 便秘 8 ( 12.7) 10 ( 16.4) 下痢 7 ( 11.1) 6 ( 9.8) 腹部不快感 4 ( 6.3) 4 ( 6.6) 嘔吐 4 ( 6.3) 4 ( 6.6) 口唇炎 7 ( 11.1) - 歯肉炎 5 ( 7.9) 1 ( 1.6) 歯肉出血 1 ( 1.6) 5 ( 8.2) 腹痛 3 ( 4.8) 3 ( 4.9) 上腹部痛 3 ( 4.8) 2 ( 3.3) 腹部膨満 3 ( 4.8) 2 ( 3.3) 消化不良 2 ( 3.2) 2 ( 3.3) 歯痛 2 ( 3.2) 1 ( 1.6) 下腹部痛 2 ( 3.2) - 口腔内不快感 - 2 ( 3.3) 歯肉痛 1 ( 1.6) 1 ( 1.6) 心窩部不快感 1 ( 1.6) 1 ( 1.6) 排便障害 - 2 ( 3.3) 腹水 1 ( 1.6) 1 ( 1.6) 変色便 1 ( 1.6) 1 ( 1.6) 胃炎 - 1 ( 1.6) 胃出血 - 1 ( 1.6) 胃潰瘍 - 1 ( 1.6) 過敏性腸症候群 1 ( 1.6) - 血便排泄 1 ( 1.6) - 口の錯感覚 - 1 ( 1.6) 口腔内出血 1 ( 1.6) - 口腔内白斑症 - 1 ( 1.6) 口腔扁平苔癬 - 1 ( 1.6) 口唇のひび割れ - 1 ( 1.6) 歯周炎 1 ( 1.6) - 歯周病 1 ( 1.6) - 歯肉腫脹 - 1 ( 1.6) 痔核 1 ( 1.6) - 小腸出血 - 1 ( 1.6) 舌炎 - 1 ( 1.6) 舌痛 - 1 ( 1.6) 腸炎 1 ( 1.6) - 吐血 - 1 ( 1.6) 排便回数増加 - 1 ( 1.6) 不正咬合 - 1 ( 1.6) 肛門潰瘍 - 1 ( 1.6) Total Number of AEs 96 90 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ペガシス／コペガス
2.7.6
個々の試験のまとめPage 135
ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
神経系障害
Total Pts With at Least one AE 39 ( 61.9) 35 ( 57.4) 頭痛 31 ( 49.2) 27 ( 44.3) 浮動性めまい 5 ( 7.9) 9 ( 14.8) 味覚異常 7 ( 11.1) 4 ( 6.6) 体位性めまい 2 ( 3.2) 5 ( 8.2) 感覚鈍麻 3 ( 4.8) 3 ( 4.9) 嗅覚錯誤 2 ( 3.2) 2 ( 3.3) 振戦 1 ( 1.6) 1 ( 1.6) 末梢性ニューロパシー 1 ( 1.6) 1 ( 1.6) 意識消失 - 1 ( 1.6) 感覚障害 - 1 ( 1.6) 記憶障害 - 1 ( 1.6) 傾眠 - 1 ( 1.6) 血管迷走神経性失神 - 1 ( 1.6) 錯感覚 1 ( 1.6) - 手根管症候群 1 ( 1.6) - 注意力障害 - 1 ( 1.6) 味覚減退 1 ( 1.6) - Total Number of AEs 55 58 筋骨格系および結合組織障害
Total Pts With at Least one AE 34 ( 54.0) 36 ( 59.0) 関節痛 20 ( 31.7) 21 ( 34.4) 背部痛 9 ( 14.3) 10 ( 16.4) 筋痛 9 ( 14.3) 9 ( 14.8) 四肢痛 3 ( 4.8) 9 ( 14.8) 筋骨格硬直 1 ( 1.6) 6 ( 9.8) 筋骨格痛 1 ( 1.6) 6 ( 9.8) 筋痙縮 4 ( 6.3) 3 ( 4.9) 頚部痛 1 ( 1.6) 2 ( 3.3) 骨関節炎 - 2 ( 3.3) 関節周囲炎 1 ( 1.6) - 筋緊張 - 1 ( 1.6) 筋力低下 1 ( 1.6) - 肩回旋筋腱板症候群 - 1 ( 1.6) 項部硬直 1 ( 1.6) - 仙腸骨炎 1 ( 1.6) - 側腹部痛 1 ( 1.6) - 多発性関節炎 - 1 ( 1.6) Total Number of AEs 53 71 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
呼吸器、胸郭および縦隔障害
Total Pts With at Least one AE 26 ( 41.3) 27 ( 44.3) 咳嗽 16 ( 25.4) 10 ( 16.4) 鼻出血 9 ( 14.3) 12 ( 19.7) 咽喉頭疼痛 4 ( 6.3) 7 ( 11.5) 湿性咳嗽 7 ( 11.1) 4 ( 6.6) 呼吸困難 5 ( 7.9) 5 ( 8.2) 鼻漏 2 ( 3.2) 2 ( 3.3) 咽喉頭不快感 - 3 ( 4.9) 鼻閉 2 ( 3.2) 1 ( 1.6) 咽頭紅斑 - 2 ( 3.3) 間質性肺疾患 1 ( 1.6) 1 ( 1.6) くしゃみ - 1 ( 1.6) アレルギー性鼻炎 - 1 ( 1.6) 血管運動性鼻炎 - 1 ( 1.6) 声帯萎縮 - 1 ( 1.6) 発声障害 1 ( 1.6) - 鼻潰瘍 1 ( 1.6) - 労作性呼吸困難 - 1 ( 1.6) 喀血 1 ( 1.6) - 扁桃肥大 - 1 ( 1.6) Total Number of AEs 49 53 眼障害
Total Pts With at Least one AE 29 ( 46.0) 23 ( 37.7) 網膜出血 12 ( 19.0) 7 ( 11.5) 網膜滲出物 7 ( 11.1) 6 ( 9.8) 網膜症 7 ( 11.1) 5 ( 8.2) 眼乾燥 1 ( 1.6) 2 ( 3.3) 眼痛 1 ( 1.6) 2 ( 3.3) 眼瞼炎 2 ( 3.2) 1 ( 1.6) 眼の異常感 1 ( 1.6) 1 ( 1.6) 眼出血 - 2 ( 3.3) 結膜炎 - 2 ( 3.3) 結膜充血 2 ( 3.2) - 結膜出血 1 ( 1.6) 1 ( 1.6) 光視症 1 ( 1.6) 1 ( 1.6) 霧視 1 ( 1.6) 1 ( 1.6) 黄斑浮腫 1 ( 1.6) - 角膜浮腫 1 ( 1.6) - 眼そう痒症 1 ( 1.6) - 眼の異物感 1 ( 1.6) - 眼脂 1 ( 1.6) - 眼充血 1 ( 1.6) - 視力低下 1 ( 1.6) - 硝子体浮遊物 1 ( 1.6) - 点状角膜炎 1 ( 1.6) - 網膜静脈閉塞 1 ( 1.6) - 網膜変性 - 1 ( 1.6) 網膜裂孔 1 ( 1.6) - 緑内障 - 1 ( 1.6) 羞明 1 ( 1.6) - 霰粒腫 - 1 ( 1.6) Total Number of AEs 48 34 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
精神障害
Total Pts With at Least one AE 18 ( 28.6) 24 ( 39.3) 不眠症 17 ( 27.0) 19 ( 31.1) 不安 2 ( 3.2) 1 ( 1.6) 失見当識 - 2 ( 3.3) 抑うつ症状 1 ( 1.6) 1 ( 1.6) うつ病 - 1 ( 1.6) 異常行動 - 1 ( 1.6) 幻視 - 1 ( 1.6) 中期不眠症 1 ( 1.6) - 不安障害 - 1 ( 1.6) 落ち着きのなさ - 1 ( 1.6) 譫妄 - 1 ( 1.6) Total Number of AEs 21 29 代謝および栄養障害
Total Pts With at Least one AE 20 ( 31.7) 19 ( 31.1) 食欲不振 14 ( 22.2) 11 ( 18.0) 食欲減退 7 ( 11.1) 6 ( 9.8) 糖尿病 - 3 ( 4.9) インスリン非依存性糖尿病 - 1 ( 1.6) 高尿酸血症 1 ( 1.6) - 低血糖症 1 ( 1.6) - Total Number of AEs 23 21 感染症および寄生虫症
Total Pts With at Least one AE 18 ( 28.6) 16 ( 26.2) 鼻咽頭炎 9 ( 14.3) 7 ( 11.5) 上気道感染 2 ( 3.2) 4 ( 6.6) 毛包炎 1 ( 1.6) 3 ( 4.9) 膀胱炎 3 ( 4.8) 1 ( 1.6) 急性気管支炎 - 2 ( 3.3) 尿路感染 1 ( 1.6) 1 ( 1.6) 外耳炎 - 1 ( 1.6) 気管支炎 - 1 ( 1.6) 股部白癬 - 1 ( 1.6) 口腔カンジダ症 1 ( 1.6) - 腰筋膿瘍 1 ( 1.6) - 歯髄炎 1 ( 1.6) - 足部白癬 - 1 ( 1.6) 麦粒腫 - 1 ( 1.6) 扁桃炎 - 1 ( 1.6) Total Number of AEs 19 24 腎および尿路障害
Total Pts With at Least one AE 6 ( 9.5) 4 ( 6.6) 頻尿 4 ( 6.3) 1 ( 1.6) 排尿困難 1 ( 1.6) 2 ( 3.3) 尿閉 1 ( 1.6) 1 ( 1.6) 夜間頻尿 1 ( 1.6) 1 ( 1.6) 神経因性膀胱 1 ( 1.6) - 尿意切迫 1 ( 1.6) - 尿管結石 1 ( 1.6) - 尿失禁 1 ( 1.6) - 膀胱炎様症状 1 ( 1.6) - Total Number of AEs 12 5 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
耳および迷路障害
Total Pts With at Least one AE 4 ( 6.3) 6 ( 9.8) 回転性めまい 2 ( 3.2) 3 ( 4.9) 耳鳴 1 ( 1.6) 3 ( 4.9) メニエール病 - 1 ( 1.6) 耳不快感 1 ( 1.6) - 耳漏 - 1 ( 1.6) 聴覚不全 1 ( 1.6) - 聴力低下 - 1 ( 1.6) 難聴 - 1 ( 1.6) 片耳難聴 1 ( 1.6) - Total Number of AEs 6 10 心臓障害
Total Pts With at Least one AE 5 ( 7.9) 3 ( 4.9) 動悸 5 ( 7.9) 2 ( 3.3) 右脚ブロック - 1 ( 1.6) 三尖弁閉鎖不全症 - 1 ( 1.6) 徐脈 - 1 ( 1.6) 心室性期外収縮 - 1 ( 1.6) 洞性頻脈 1 ( 1.6) - Total Number of AEs 6 6 血液およびリンパ系障害
Total Pts With at Least one AE 5 ( 7.9) 3 ( 4.9) 貧血 5 ( 7.9) 3 ( 4.9) Total Number of AEs 5 3 血管障害
Total Pts With at Least one AE 3 ( 4.8) 3 ( 4.9) 高血圧 1 ( 1.6) 2 ( 3.3) ほてり - 1 ( 1.6) リンパ浮腫 1 ( 1.6) - 低血圧 1 ( 1.6) - Total Number of AEs 3 3 生殖系および乳房障害
Total Pts With at Least one AE 2 ( 3.2) 3 ( 4.9) 良性前立腺肥大症 1 ( 1.6) 1 ( 1.6) 陰嚢血瘤 - 1 ( 1.6) 外陰部出血 - 1 ( 1.6) 月経過多 1 ( 1.6) - 乳房腫脹 1 ( 1.6) - Total Number of AEs 3 3 良性、悪性および詳細不明の新生物
（嚢胞およびポリープを含む）
Total Pts With at Least one AE 4 ( 6.3) 1 ( 1.6) 脂漏性角化症 1 ( 1.6) 1 ( 1.6) 肝の悪性新生物 1 ( 1.6) - 黒子 1 ( 1.6) - 皮膚乳頭腫 1 ( 1.6) - Total Number of AEs 4 1 傷害、中毒および処置合併症
Total Pts With at Least one AE 2 ( 3.2) 1 ( 1.6) 挫傷 - 1 ( 1.6) 術後創合併症 1 ( 1.6) - 転倒 1 ( 1.6) - 背部損傷 - 1 ( 1.6) Total Number of AEs 2 2 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
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ae11sesum_sppa Summary of Adverse Events related to Trial Treatment Related Adverse Events
Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
__________________________________________________________________
Body System/ PEG-IFN PEG-IFN Adverse Event 180 mcg 90 mcg + RBV + RBV N = 63 N = 61 No. (%) No. (%) __________________________________________________________________
肝胆道系障害
Total Pts With at Least one AE 2 ( 3.2) 1 ( 1.6) 脂肪肝 2 ( 3.2) - 過形成性胆嚢症 - 1 ( 1.6) Total Number of AEs 2 1 内分泌障害
Total Pts With at Least one AE 1 ( 1.6) 1 ( 1.6) バセドウ病 1 ( 1.6) - 甲状腺機能低下症 1 ( 1.6) - 自己免疫性甲状腺炎 - 1 ( 1.6) Total Number of AEs 2 1 __________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Multiple occurrences of the same adverse event in one individual counted only once.
AE11 24MAR2010:09:29:25 (8 of 8)
［
5.3.5.1-1
表12.2.3.2-1
の再掲］ペガシス／コペガス
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表 2.7.6.6-3 有害事象の重症度別発現例数（JV19595，SAFETY）
ae17aesev_sppa Summary of Adverse Events by Trial Treatment, Body System and Intensity Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
Treatment: PEG-IFN 180 mcg + RBV; N = 63
_________________________________________________________________________________________
Body System/ Intensity
Adverse Event __________________________________________
Total Mild Moderate Severe No. (%) No. (%) No. (%) No. (%) _________________________________________________________________________________________
ALL BODY SYSTEMS
Total Pts with at Least one AE 63 (100.0) 63 (100.0) 52 ( 82.5) 4 ( 6.3) Total Number of AEs 1476 1297 173 6 臨床検査
Total Pts With at Least one AE 63 (100.0) 61 ( 96.8) 28 ( 44.4) 1 ( 1.6) 好中球数減少 61 ( 96.8) 50 ( 79.4) 11 ( 17.5) - 白血球数減少 57 ( 90.5) 53 ( 84.1) 4 ( 6.3) - ヘモグロビン減少 54 ( 85.7) 45 ( 71.4) 9 ( 14.3) - 赤血球数減少 53 ( 84.1) 50 ( 79.4) 3 ( 4.8) - 血小板数減少 50 ( 79.4) 34 ( 54.0) 16 ( 25.4) - ヘマトクリット減少 43 ( 68.3) 39 ( 61.9) 4 ( 6.3) - リンパ球数減少 38 ( 60.3) 36 ( 57.1) 2 ( 3.2) - アスパラギン酸アミノトランスフ 26 ( 41.3) 19 ( 30.2) 6 ( 9.5) 1 ( 1.6) ェラーゼ増加
アラニン・アミノトランスフェラ 26 ( 41.3) 20 ( 31.7) 5 ( 7.9) 1 ( 1.6) ーゼ増加
γ－グルタミルトランスフェラー 22 ( 34.9) 20 ( 31.7) 2 ( 3.2) - ゼ増加
体重減少 13 ( 20.6) 10 ( 15.9) 3 ( 4.8) - 血中リン減少 12 ( 19.0) 11 ( 17.5) 1 ( 1.6) - 血中トリグリセリド増加 10 ( 15.9) 10 ( 15.9) - - 血中非抱合ビリルビン増加 9 ( 14.3) 9 ( 14.3) - - 抱合ビリルビン増加 7 ( 11.1) 7 ( 11.1) - - Ｃ－反応性蛋白増加 5 ( 7.9) 5 ( 7.9) - - 心拍数増加 5 ( 7.9) 5 ( 7.9) - - 血中カルシウム減少 4 ( 6.3) 3 ( 4.8) 1 ( 1.6) - 血中ビリルビン増加 4 ( 6.3) 4 ( 6.3) - - 総蛋白増加 4 ( 6.3) 4 ( 6.3) - - 遊離トリヨードチロニン減少 4 ( 6.3) 4 ( 6.3) - - 血中アルカリホスファターゼ増加 3 ( 4.8) 3 ( 4.8) - - 血中甲状腺刺激ホルモン増加 3 ( 4.8) 3 ( 4.8) - - 尿中蛋白陽性 2 ( 3.2) 2 ( 3.2) - - ビタミンＫ欠乏時産生蛋白ＩＩ上 1 ( 1.6) 1 ( 1.6) - - 昇
α１フェトプロテイン増加 1 ( 1.6) 1 ( 1.6) - - 眼圧上昇 1 ( 1.6) 1 ( 1.6) - - 血中ブドウ糖増加 1 ( 1.6) - 1 ( 1.6) - 血中甲状腺刺激ホルモン減少 1 ( 1.6) 1 ( 1.6) - - 血中乳酸脱水素酵素増加 1 ( 1.6) 1 ( 1.6) - - 血中尿酸増加 1 ( 1.6) - 1 ( 1.6) - 呼吸数増加 1 ( 1.6) - 1 ( 1.6) - 好塩基球数増加 1 ( 1.6) 1 ( 1.6) - - 好酸球数減少 1 ( 1.6) 1 ( 1.6) - - 好中球数増加 1 ( 1.6) 1 ( 1.6) - - 細胞マーカー増加 1 ( 1.6) 1 ( 1.6) - - 収縮期血圧低下 1 ( 1.6) 1 ( 1.6) - - 潜血陽性 1 ( 1.6) 1 ( 1.6) - - 単球数減少 1 ( 1.6) 1 ( 1.6) - - 尿中ブドウ糖陽性 1 ( 1.6) 1 ( 1.6) - - 尿中血陽性 1 ( 1.6) 1 ( 1.6) - - 尿比重増加 1 ( 1.6) 1 ( 1.6) - - 尿量減少 1 ( 1.6) 1 ( 1.6) - - 白血球数増加 1 ( 1.6) 1 ( 1.6) - - 皮膚テスト陽性 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 536 464 70 2 _________________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Only the most severe intensity is counted for multiple occurrences of the same adverse event in one individual.
Any difference between the total number and sum of AEs is due to missing investigators assessment of intensity.
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ae17aesev_sppa Summary of Adverse Events by Trial Treatment, Body System and Intensity Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
Treatment: PEG-IFN 180 mcg + RBV; N = 63
_________________________________________________________________________________________
Body System/ Intensity
Adverse Event __________________________________________
Total Mild Moderate Severe No. (%) No. (%) No. (%) No. (%) _________________________________________________________________________________________
全身障害および投与局所様態
Total Pts With at Least one AE 62 ( 98.4) 62 ( 98.4) 30 ( 47.6) - 発熱 61 ( 96.8) 34 ( 54.0) 27 ( 42.9) - 倦怠感 47 ( 74.6) 46 ( 73.0) 1 ( 1.6) - 熱感 17 ( 27.0) 16 ( 25.4) 1 ( 1.6) - 注射部位そう痒感 14 ( 22.2) 13 ( 20.6) 1 ( 1.6) - 注射部位紅斑 14 ( 22.2) 14 ( 22.2) - - 悪寒 11 ( 17.5) 10 ( 15.9) 1 ( 1.6) - 注射部位内出血 6 ( 9.5) 6 ( 9.5) - - 口渇 5 ( 7.9) 4 ( 6.3) 1 ( 1.6) - 注射部位発疹 4 ( 6.3) 3 ( 4.8) 1 ( 1.6) - 易刺激性 3 ( 4.8) 3 ( 4.8) - - 異常感 3 ( 4.8) 3 ( 4.8) - - 胸痛 3 ( 4.8) 3 ( 4.8) - - 末梢性浮腫 3 ( 4.8) 2 ( 3.2) 1 ( 1.6) - 冷感 3 ( 4.8) 3 ( 4.8) - - 穿刺部位疼痛 2 ( 3.2) 2 ( 3.2) - - 注射部位熱感 2 ( 3.2) 2 ( 3.2) - - 局所腫脹 1 ( 1.6) 1 ( 1.6) - - 血管穿刺部位内出血 1 ( 1.6) 1 ( 1.6) - - 血管穿刺部位反応 1 ( 1.6) 1 ( 1.6) - - 注射部位腫脹 1 ( 1.6) 1 ( 1.6) - - 注射部位出血 1 ( 1.6) 1 ( 1.6) - - 注射部位変色 1 ( 1.6) 1 ( 1.6) - - 疲労 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 205 171 34 - 皮膚および皮下組織障害
Total Pts With at Least one AE 54 ( 85.7) 53 ( 84.1) 11 ( 17.5) - そう痒症 30 ( 47.6) 28 ( 44.4) 2 ( 3.2) - 発疹 19 ( 30.2) 18 ( 28.6) 1 ( 1.6) - 脱毛症 14 ( 22.2) 14 ( 22.2) - - 全身性そう痒症 12 ( 19.0) 11 ( 17.5) 1 ( 1.6) - 紅斑 11 ( 17.5) 10 ( 15.9) 1 ( 1.6) - 皮膚乾燥 6 ( 9.5) 6 ( 9.5) - - 湿疹 5 ( 7.9) 5 ( 7.9) - - 皮下出血 5 ( 7.9) 5 ( 7.9) - - 皮脂欠乏性湿疹 4 ( 6.3) 3 ( 4.8) 1 ( 1.6) - 貨幣状湿疹 3 ( 4.8) 3 ( 4.8) - - 脂漏性皮膚炎 3 ( 4.8) 3 ( 4.8) - - 色素沈着障害 2 ( 3.2) 2 ( 3.2) - - 多汗症 2 ( 3.2) 2 ( 3.2) - - 皮膚炎 2 ( 3.2) 2 ( 3.2) - - 冷汗 2 ( 3.2) 2 ( 3.2) - - 痒疹 2 ( 3.2) - 2 ( 3.2) - さじ状爪 1 ( 1.6) 1 ( 1.6) - - そう痒性皮疹 1 ( 1.6) 1 ( 1.6) - - 過角化 1 ( 1.6) 1 ( 1.6) - - 紅色汗疹 1 ( 1.6) 1 ( 1.6) - - 水疱 1 ( 1.6) 1 ( 1.6) - - 接触性皮膚炎 1 ( 1.6) 1 ( 1.6) - - 全身性皮疹 1 ( 1.6) 1 ( 1.6) - - 多形紅斑 1 ( 1.6) - 1 ( 1.6) - 中毒性皮疹 1 ( 1.6) - 1 ( 1.6) - 皮膚潰瘍 1 ( 1.6) - 1 ( 1.6) - 皮膚熱感 1 ( 1.6) 1 ( 1.6) - - 薬疹 1 ( 1.6) 1 ( 1.6) - - 蕁麻疹 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 135 124 11 - _________________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Only the most severe intensity is counted for multiple occurrences of the same adverse event in one individual.
Any difference between the total number and sum of AEs is due to missing investigators assessment of intensity.
AE17 24MAR2010:09:43:26 (2 of 19)
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2.7.6
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ae17aesev_sppa Summary of Adverse Events by Trial Treatment, Body System and Intensity Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
Treatment: PEG-IFN 180 mcg + RBV; N = 63
_________________________________________________________________________________________
Body System/ Intensity
Adverse Event __________________________________________
Total Mild Moderate Severe No. (%) No. (%) No. (%) No. (%) _________________________________________________________________________________________
胃腸障害
Total Pts With at Least one AE 48 ( 76.2) 47 ( 74.6) 7 ( 11.1) - 悪心 16 ( 25.4) 16 ( 25.4) - - 口内炎 13 ( 20.6) 11 ( 17.5) 2 ( 3.2) - 胃不快感 11 ( 17.5) 11 ( 17.5) - - 下痢 11 ( 17.5) 10 ( 15.9) 1 ( 1.6) - 便秘 9 ( 14.3) 9 ( 14.3) - - 口唇炎 7 ( 11.1) 6 ( 9.5) 1 ( 1.6) - 嘔吐 6 ( 9.5) 4 ( 6.3) 2 ( 3.2) - 歯肉炎 5 ( 7.9) 4 ( 6.3) 1 ( 1.6) - 上腹部痛 5 ( 7.9) 5 ( 7.9) - - 腹痛 4 ( 6.3) 4 ( 6.3) - - 腹部不快感 4 ( 6.3) 4 ( 6.3) - - 下腹部痛 3 ( 4.8) 3 ( 4.8) - - 歯周炎 3 ( 4.8) 3 ( 4.8) - - 歯痛 3 ( 4.8) 3 ( 4.8) - - 歯肉腫脹 3 ( 4.8) 3 ( 4.8) - - 歯肉痛 3 ( 4.8) 3 ( 4.8) - - 消化不良 3 ( 4.8) 3 ( 4.8) - - 腹部膨満 3 ( 4.8) 3 ( 4.8) - - 血便排泄 2 ( 3.2) 2 ( 3.2) - - 痔核 2 ( 3.2) 1 ( 1.6) 1 ( 1.6) - 腹水 2 ( 3.2) 2 ( 3.2) - - 齲歯 2 ( 3.2) 2 ( 3.2) - - 胃炎 1 ( 1.6) 1 ( 1.6) - - 胃静脈瘤 1 ( 1.6) 1 ( 1.6) - - 過敏性腸症候群 1 ( 1.6) 1 ( 1.6) - - 結腸ポリープ 1 ( 1.6) 1 ( 1.6) - - 口腔内出血 1 ( 1.6) 1 ( 1.6) - - 口腔内痛 1 ( 1.6) - 1 ( 1.6) - 口腔粘膜びらん 1 ( 1.6) - 1 ( 1.6) - 口腔扁平苔癬 1 ( 1.6) - 1 ( 1.6) - 口唇びらん 1 ( 1.6) 1 ( 1.6) - - 口唇腫脹 1 ( 1.6) 1 ( 1.6) - - 歯周病 1 ( 1.6) 1 ( 1.6) - - 歯肉出血 1 ( 1.6) 1 ( 1.6) - - 食道静脈瘤出血 1 ( 1.6) - 1 ( 1.6) - 心窩部不快感 1 ( 1.6) 1 ( 1.6) - - 腸炎 1 ( 1.6) 1 ( 1.6) - - 変色便 1 ( 1.6) 1 ( 1.6) - - 鼡径ヘルニア 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 137 125 12 - _________________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Only the most severe intensity is counted for multiple occurrences of the same adverse event in one individual.
Any difference between the total number and sum of AEs is due to missing investigators assessment of intensity.
AE17 24MAR2010:09:43:26 (3 of 19)
ペガシス／コペガス
2.7.6
個々の試験のまとめPage 143
ae17aesev_sppa Summary of Adverse Events by Trial Treatment, Body System and Intensity Protocol(s): JV19595
Analysis: AS SELECTED Center: ALL CENTERS Analysis: SAFETY
Treatment: PEG-IFN 180 mcg + RBV; N = 63
_________________________________________________________________________________________
Body System/ Intensity
Adverse Event __________________________________________
Total Mild Moderate Severe No. (%) No. (%) No. (%) No. (%) _________________________________________________________________________________________
筋骨格系および結合組織障害
Total Pts With at Least one AE 44 ( 69.8) 43 ( 68.3) 5 ( 7.9) - 関節痛 23 ( 36.5) 19 ( 30.2) 4 ( 6.3) - 背部痛 16 ( 25.4) 15 ( 23.8) 1 ( 1.6) - 筋痛 10 ( 15.9) 10 ( 15.9) - - 四肢痛 7 ( 11.1) 6 ( 9.5) 1 ( 1.6) - 筋痙縮 5 ( 7.9) 5 ( 7.9) - - 筋骨格痛 2 ( 3.2) 2 ( 3.2) - - 変形性脊椎炎 2 ( 3.2) 2 ( 3.2) - - 鼡径部痛 2 ( 3.2) 1 ( 1.6) 1 ( 1.6) - 関節周囲炎 1 ( 1.6) - 1 ( 1.6) - 筋骨格硬直 1 ( 1.6) 1 ( 1.6) - - 筋力低下 1 ( 1.6) 1 ( 1.6) - - 頚部痛 1 ( 1.6) 1 ( 1.6) - - 項部硬直 1 ( 1.6) 1 ( 1.6) - - 骨関節炎 1 ( 1.6) 1 ( 1.6) - - 脊椎靱帯骨化症 1 ( 1.6) 1 ( 1.6) - - 仙腸骨炎 1 ( 1.6) 1 ( 1.6) - - 側腹部痛 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 76 68 8 - 呼吸器、胸郭および縦隔障害
Total Pts With at Least one AE 41 ( 65.1) 40 ( 63.5) 3 ( 4.8) 1 ( 1.6) 咳嗽 24 ( 38.1) 21 ( 33.3) 3 ( 4.8) - 咽喉頭疼痛 12 ( 19.0) 12 ( 19.0) - - 鼻出血 11 ( 17.5) 11 ( 17.5) - - 湿性咳嗽 8 ( 12.7) 7 ( 11.1) 1 ( 1.6) - 呼吸困難 5 ( 7.9) 5 ( 7.9) - - 鼻漏 5 ( 7.9) 5 ( 7.9) - - 鼻閉 4 ( 6.3) 3 ( 4.8) 1 ( 1.6) - 発声障害 2 ( 3.2) 2 ( 3.2) - - くしゃみ 1 ( 1.6) 1 ( 1.6) - - 咽喉頭不快感 1 ( 1.6) 1 ( 1.6) - - 咽頭紅斑 1 ( 1.6) 1 ( 1.6) - - 間質性肺疾患 1 ( 1.6) - - 1 ( 1.6) 低酸素症 1 ( 1.6) 1 ( 1.6) - - 鼻潰瘍 1 ( 1.6) 1 ( 1.6) - - 鼻嚢胞 1 ( 1.6) 1 ( 1.6) - - 喀血 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 79 73 5 1 神経系障害
Total Pts With at Least one AE 41 ( 65.1) 40 ( 63.5) 3 ( 4.8) - 頭痛 31 ( 49.2) 29 ( 46.0) 2 ( 3.2) - 味覚異常 7 ( 11.1) 7 ( 11.1) - - 浮動性めまい 6 ( 9.5) 6 ( 9.5) - - 感覚鈍麻 5 ( 7.9) 5 ( 7.9) - - 体位性めまい 2 ( 3.2) 2 ( 3.2) - - 末梢性ニューロパシー 2 ( 3.2) 1 ( 1.6) 1 ( 1.6) - 嗅覚錯誤 2 ( 3.2) 2 ( 3.2) - - 錯感覚 1 ( 1.6) 1 ( 1.6) - - 手根管症候群 1 ( 1.6) 1 ( 1.6) - - 振戦 1 ( 1.6) 1 ( 1.6) - - 頭部不快感 1 ( 1.6) 1 ( 1.6) - - 味覚減退 1 ( 1.6) 1 ( 1.6) - - Total Number of AEs 60 57 3 - _________________________________________________________________________________________
Investigator text for Adverse Events encoded using MedDRA version 9.1.
Percentages are based on N.
Only the most severe intensity is counted for multiple occurrences of the same adverse event in one individual.
Any difference between the total number and sum of AEs is due to missing investigators assessment of intensity.
AE17 24MAR2010:09:43:26 (4 of 19)