ポリープを含む）/転移性非小細胞肺癌/転移 19MAR2010 Permanently withdrawn
005-0505 71/F/White 眼障害/視力低下/15文字の視力低下 SEVERE/No No No 04NOV2009 545 Drug
Permanently withdrawn
Not Recovered / Not Resolved Source: 5.3.5.4-1 702試験のListing 14.3.2.3
無作為化集団）及び表 2.7.6.13- 33（安全性解析対象集団）に示す。全無作為化集団における 治験対象眼の TEAE、僚眼の TEAE 及び眼以外の TEAE の発現例数及び発現率に関して、バイアル 群とプレフィルドシリンジ群の比較をそれぞれ表 2.7.6.13- 34、表 2.7.6.13- 36及び表 37に示す。また、安全性解析対象集団における同様の結果をそれぞれ表 2.7.6.13-35、表 2.7.6.13- 37及び表 2.7.6.13- 39に示す。
最も高頻度に報告された事象〔白内障（cataract）、網膜出血（retinal hemorrhage）、視力低 下（reduced VA）、結膜出血（conjunctival hemorrhage）及び眼瞼炎（blepharitis）〕を含め、
無作為化後に発現した治験対象眼における TEAE の発現率は、バイアル群の方が高かった
（76.0％対 58.6％）が、その差の臨床的な意味は明らかではなかった（表 2.7.6.13- 34）。
僚眼における TEAE の発現率は、無作為化前には両投与群で同程度（バイアル群 40.0％、プレフ ィルドシリンジ群 43.4％）であったが、無作為化後にはバイアル群のほうが高かった（バイア ル群 70.0％、プレフィルドシリンジ群 50.5％、表 2.7.6.13- 36）。
眼以外の TEAE の発現率は両群で同じ（バイアル群 88.0％、プレフィルドシリンジ群 87.9％）で あ っ た （ 表 2.7.6.13- 38 ） 。 眼 以 外 の TEAE と し て 下 痢 （ diarrhea ） 、 鼻 咽 頭 炎
（nasopharyngitis）、気管支炎（bronchitis）、尿路感染（urinary tract infection）、副鼻
腔炎（sinusitis）、上気道感染（upper respiratory tract infection）、転倒（fall）、関節
炎（arthritis）、変形性関節症（osteoarthritis）及び高血圧（hypertension）］が比較的高
頻度に報告されたが、それぞれの発現率は概して低かった（表 2.7.6.13- 38）。
Any non ocular AE 33 (66.0%) 44 (88.0%) 65 (65.7%) 87 (87.9%) 98 (65.8%) 131 (87.9%)
Any treatment related AE 1 (2.0%) 0 1 (1.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
Any ocular treatment related AE 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%) 0
Study eye 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%) 0
Fellow eye 0 0 0 0 0 0
Any non ocular treatment related AE 0 0 0 1 (1.0%) 0 1 (0.7%)
Maximum intensity for any ocular AE
Mild 23 (46.0%) 39 (78.0%) 56 (56.6%) 65 (65.7%) 79 (53.0%) 104 (69.8%)
Moderate 11 (22.0%) 12 (24.0%) 27 (27.3%) 27 (27.3%) 38 (25.5%) 39 (26.2%)
Severe 1 (2.0%) 3 (6.0%) 3 (3.0%) 5 (5.1%) 4 (2.7%) 8 (5.4%)
Study Eye 1 (2.0%) 2 (4.0%) 2 (2.0%) 4 (4.0%) 3 (2.0%) 6 (4.0%)
Fellow Eye 0 2 (4.0%) 1 (1.0%) 1 (1.0%) 1 (0.7%) 3 (2.0%)
Maximum intensity for any non-ocular AE
Mild 22 (44.0%) 39 (78.0%) 55 (55.6%) 77 (77.8%) 77 (51.7%) 116 (77.9%)
Moderate 19 (38.0%) 17 (34.0%) 32 (32.3%) 55 (55.6%) 51 (34.2%) 72 (48.3%)
Severe 5 (10.0%) 12 (24.0%) 6 (6.1%) 16 (16.2%) 11 (7.4%) 28 (18.8%)
Study Eye 0 0 0 0 0 0
Fellow Eye 5 (10.0%) 12 (24.0%) 6 (6.1%) 16 (16.2%) 11 (7.4%) 28 (18.8%)
Any SAE 9 (18.0%) 16 (32.0%) 13 (13.1%) 33 (33.3%) 22 (14.8%) 49 (32.9%)
Any injection related SAE 1 (2.0%) 0 0 1 (1.0%) 1 (0.7%) 1 (0.7%)
Any AEs leading to withdrawal from study 0 2 (4.0%) 0 1 (1.0%) 0 3 (2.0%)
Discontinuation of study drug due to AEs 0 1 (2.0%) 0 2 (2.0%) 0 3 (2.0%)
Any Death due to AE 0 2 (4.0%) 0 3 (3.0%) 0 5 (3.4%)
Any non ocular AE 52 (96.3%) 76 (92.7%) 128 (94.1%)
Any treatment related AE 1 (1.9%) 2 (2.4%) 3 (2.2%)
Any ocular treatment related AE 1 (1.9%) 1 (1.2%) 2 (1.5%)
Study eye 1 (1.9%) 1 (1.2%) 2 (1.5%)
Fellow eye 0 0 0
Any non ocular treatment related AE 0 1 (1.2%) 1 (0.7%)
Maximum intensity for any ocular AE
MILD 43 (79.6%) 68 (82.9%) 111 (81.6%)
MODERATE 21 (38.9%) 40 (48.8%) 61 (44.9%)
SEVERE 4 (7.4%) 7 (8.5%) 11 (8.1%)
Maximum intensity for any non ocular AE
MILD 45 (83.3%) 70 (85.4%) 115 (84.6%)
MODERATE 31 (57.4%) 56 (68.3%) 87 (64.0%)
SEVERE 17 (31.5%) 17 (20.7%) 34 (25.0%)
Any SAE 20 (37.0%) 37 (45.1%) 57 (41.9%)
Any injection related SAE 1 (1.9%) 1 (1.2%) 2 (1.5%)
Any AEs leading to withdrawal from study 2 (3.7%) 1 (1.2%) 3 (2.2%)
Discontinuation of study drug due to AEs 1 (1.9%) 2 (2.4%) 3 (2.2%)
Any death due to AE 4 (7.4%) 2 (2.4%) 6 (4.4%)
Note: Cutoff date for the data is 20 . Source: 5.3.5.4-1 702試験のpost-text table 14.3.1/4
角膜ジストロフィー 1 (2.0%) 1 (2.0%) 0 1 (1.0%) 1 (0.7%) 2 (1.3%)
睫毛重生 1 (2.0%) 0 0 0 1 (0.7%) 0
眼障害 22 (44.0%) 37 (74.0%) 52 (52.5%) 52 (52.5%) 74 (49.7%) 89 (59.7%)
前房内細胞 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
角膜リポイド環 0 0 0 1 (1.0%) 0 1 (0.7%)
眼瞼炎 1 (2.0%) 5 (10.0%) 1 (1.0%) 2 (2.0%) 2 (1.3%) 7 (4.7%)
アレルギー性眼瞼炎 0 0 1 (1.0%) 0 1 (0.7%) 0
眼瞼皮膚弛緩症 0 1 (2.0%) 2 (2.0%) 0 2 (1.3%) 1 (0.7%)
白内障 2 (4.0%) 7 (14.0%) 5 (5.1%) 9 (9.1%) 7 (4.7%) 16 (10.7%)
皮質白内障 1 (2.0%) 1 (2.0%) 0 1 (1.0%) 1 (0.7%) 2 (1.3%) 核性白内障 1 (2.0%) 2 (4.0%) 2 (2.0%) 1 (1.0%) 3 (2.0%) 3 (2.0%) 嚢下白内障 0 1 (2.0%) 3 (3.0%) 3 (3.0%) 3 (2.0%) 4 (2.7%)
脈絡網膜障害 0 0 1 (1.0%) 0 1 (0.7%) 0
結膜出血 4 (8.0%) 6 (12.0%) 8 (8.1%) 8 (8.1%) 12 (8.1%) 14 (9.4%)
結膜充血 0 0 1 (1.0%) 0 1 (0.7%) 0
結膜浮腫 1 (2.0%) 0 0 0 1 (0.7%) 0
結膜炎 2 (4.0%) 2 (4.0%) 0 0 2 (1.3%) 2 (1.3%)
アレルギー性結膜炎 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
角膜浮腫 1 (2.0%) 0 0 1 (1.0%) 1 (0.7%) 1 (0.7%)
網膜色素上皮剥離 2 (4.0%) 0 1 (1.0%) 2 (2.0%) 3 (2.0%) 2 (1.3%)
糖尿病性網膜症 0 2 (4.0%) 0 0 0 2 (1.3%)
複視 0 0 1 (1.0%) 0 1 (0.7%) 0
眼乾燥 1 (2.0%) 2 (4.0%) 3 (3.0%) 2 (2.0%) 4 (2.7%) 4 (2.7%)
眼のアレルギー 0 1 (2.0%) 1 (1.0%) 2 (2.0%) 1 (0.7%) 3 (2.0%)
眼脂 0 2 (4.0%) 2 (2.0%) 0 2 (1.3%) 2 (1.3%)
眼刺激 0 0 2 (2.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
眼痛 0 1 (2.0%) 7 (7.1%) 3 (3.0%) 7 (4.7%) 4 (2.7%)
眼そう痒症 1 (2.0%) 0 5 (5.1%) 4 (4.0%) 6 (4.0%) 4 (2.7%)
眼瞼出血 0 0 ｂ 1 (1.0%) 0 1 (0.7%) 0
眼瞼びらん 0 0 1 (1.0%) 0 1 (0.7%) 0
眼瞼浮腫 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
眼瞼下垂 0 0 1 (1.0%) 0 1 (0.7%) 0
眼の異物感 0 0 0 6 (6.1%) 0 6 (4.0%)
緑内障 0 0 0 1 (1.0%) 0 1 (0.7%)
星状硝子体症 0 0 0 1 (1.0%) 0 1 (0.7%)
虹彩癒着 0 0 0 1 (1.0%) 0 1 (0.7%)
乾性角結膜炎 1 (2.0%) 1 (2.0%) 0 0 1 (0.7%) 1 (0.7%)
涙液分泌低下 0 1 (2.0%) 0 0 0 1 (0.7%)
流涙増加 0 0 2 (2.0%) 3 (3.0%) 2 (1.3%) 3 (2.0%)
黄斑嚢胞 0 1 (2.0%) 0 0 0 1 (0.7%)
黄斑変性 3 (6.0%) 3 (6.0%) 3 (3.0%) 4 (4.0%) 6 (4.0%) 7 (4.7%)
黄斑円孔 0 0 1 (1.0%) 0 1 (0.7%) 0
黄斑浮腫 0 1 (2.0%) 1 (1.0%) 1 (1.0%) 1 (0.7%) 2 (1.3%)
黄斑偽円孔 0 0 1 (1.0%) 0 1 (0.7%) 0
黄斑症 0 1 (2.0%) 0 3 (3.0%) 0 4 (2.7%)
マイボーム腺機能不全 0 1 (2.0%) 0 0 0 1 (0.7%)
変視症 0 1 (2.0%) 1 (1.0%) 1 (1.0%) 1 (0.7%) 2 (1.3%)
眼充血 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
1 (2.0%) 1 (2.0%) 0 0 1 (0.7%) 1 (0.7%)
光視症 0 2 (4.0%) 0 1 (1.0%) 0 3 (2.0%) 後嚢部混濁 1 (2.0%) 2 (4.0%) 4 (4.0%) 2 (2.0%) 5 (3.4%) 4 (2.7%)
翼状片 0 1 (2.0%) 0 0 0 1 (0.7%)
点状角膜炎 1 (2.0%) 1 (2.0%) 1 (1.0%) 3 (3.0%) 2 (1.3%) 4 (2.7%)
網膜血管瘤 0 0 0 1 (1.0%) 0 1 (0.7%)
網膜動脈塞栓症 0 0 0 1 (1.0%) 0 1 (0.7%)
網膜変性 0 2 (4.0%) 1 (1.0%) 2 (2.0%) 1 (0.7%) 4 (2.7%)
網膜滲出物 1 (2.0%) 1 (2.0%) 2 (2.0%) 1 (1.0%) 3 (2.0%) 2 (1.3%)
網膜出血 4 (8.0%) 8 (16.0%) 4 (4.0%) 8 (8.1%) 8 (5.4%) 16 (10.7%)
網膜血管新生 0 0 0 1 (1.0%) 0 1 (0.7%)
網膜浮腫 1 (2.0%) 2 (4.0%) 1 (1.0%) 2 (2.0%) 2 (1.3%) 4 (2.7%)
網膜色素上皮裂孔 0 1 (2.0%) 1 (1.0%) 3 (3.0%) 1 (0.7%) 4 (2.7%)
網膜色素上皮症 0 0 1 (1.0%) 0 1 (0.7%) 0
網膜裂孔 0 0 1 (1.0%) 0 1 (0.7%) 0
暗点 1 (2.0%) 1 (2.0%) 0 0 1 (0.7%) 1 (0.7%)
網膜下線維症 1 (2.0%) 0 3 (3.0%) 2 (2.0%) 4 (2.7%) 2 (1.3%)
霧視 1 (2.0%) 2 (4.0%) 3 (3.0%) 0 4 (2.7%) 2 (1.3%)
視力低下 3 (6.0%) 8 (16.0%) 5 (5.1%) 7 (7.1%) 8 (5.4%) 15 (10.1%)
硝子体細胞 1 (2.0%) 0 0 0 1 (0.7%) 0
硝子体癒着 0 0 0 1 (1.0%) 0 1 (0.7%)
硝子体変性 0 0 1 (1.0%) 0 1 (0.7%) 0
硝子体剥離 1 (2.0%) 5 (10.0%) 2 (2.0%) 1 (1.0%) 3 (2.0%) 6 (4.0%) 硝子体浮遊物 0 2 (4.0%) 4 (4.0%) 7 (7.1%) 4 (2.7%) 9 (6.0%)
硝子体混濁 0 0 1 (1.0%) 0 1 (0.7%) 0
注射部位紅斑 0 0 0 1 (1.0%) 0 1 (0.7%) 注射部位疼痛 0 0 4 (4.0%) 4 (4.0%) 4 (2.7%) 4 (2.7%)
感染症および寄生虫症 0 0 0 2 (2.0%) 0 2 (1.3%)
眼帯状疱疹 0 0 0 1 (1.0%) 0 1 (0.7%)
麦粒腫 0 0 0 1 (1.0%) 0 1 (0.7%)
傷害、中毒および処置合併症 0 1 (2.0%) 1 (1.0%) 4 (4.0%) 1 (0.7%) 5 (3.4%)
角膜擦過傷 0 0 0 2 (2.0%) 0 2 (1.3%)
眼外傷 0 0 0 1 (1.0%) 0 1 (0.7%)
眼の貫通性外傷 0 0 0 1 (1.0%) 0 1 (0.7%)
傷害、中毒および処置合併症
黄斑部瘢痕 0 1 (2.0%) 0 0 0 1 (0.7%)
過量投与 0 0 1 (1.0%) 0 1 (0.7%) 0
処置後浮腫 0 0 0 1 (1.0%) 0 1 (0.7%)
臨床検査 2 (4.0%) 0 5 (5.1%) 4 (4.0%) 7 (4.7%) 4 (2.7%)
眼圧上昇 1 (2.0%) 0 4 (4.0%) 4 (4.0%) 5 (3.4%) 4 (2.7%)
視神経乳頭陥凹／乳頭比増加 1 (2.0%) 0 0 0 1 (0.7%) 0
視野検査異常 0 0 1 (1.0%) 0 1 (0.7%) 0
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）
0 1 (2.0%) 0 0 0 1 (0.7%)
眼瞼乳頭腫 0 1 (2.0%) 0 0 0 1 (0.7%)
神経系障害 0 0 1 (1.0%) 0 1 (0.7%) 0
0 0 1 (1.0%) 0 1 (0.7%) 0
顔面腫脹 0 0 0 1 (1.0%) 0 1 (0.7%) Source: 5.3.5.4-1 702試験のpost-text table 14.3.1/5
結膜出血 8 (14.8%) 14 (17.1%) 22 (16.2%)
視力低下 12 (22.2%) 10 (12.2%) 22 (16.2%)
白内障 9 (16.7%) 11 (13.4%) 20 (14.7%)
網膜出血 10 (18.5%) 10 (12.2%) 20 (14.7%)
黄斑変性 6 (11.1%) 7 (8.5%) 13 (9.6%)
硝子体浮遊物 2 (3.7%) 10 (12.2%) 12 (8.8%)
眼痛 1 (1.9%) 9 (11.0%) 10 (7.4%)
眼そう痒症 2 (3.7%) 7 (8.5%) 9 (6.6%)
後嚢部混濁 3 (5.6%) 6 (7.3%) 9 (6.6%)
硝子体剥離 6 (11.1%) 3 (3.7%) 9 (6.6%)
眼瞼炎 6 (11.1%) 2 (2.4%) 8 (5.9%)
眼乾燥 3 (5.6%) 5 (6.1%) 8 (5.9%)
嚢下白内障 1 (1.9%) 6 (7.3%) 7 (5.1%)
核性白内障 3 (5.6%) 3 (3.7%) 6 (4.4%)
眼の異物感 0 6 (7.3%) 6 (4.4%)
網膜色素上皮剥離 2 (3.7%) 3 (3.7%) 5 (3.7%)
流涙増加 0 5 (6.1%) 5 (3.7%)
網膜変性 2 (3.7%) 3 (3.7%) 5 (3.7%)
網膜滲出物 2 (3.7%) 3 (3.7%) 5 (3.7%)
網膜色素上皮裂孔 1 (1.9%) 4 (4.9%) 5 (3.7%)
網膜下線維症 2 (3.7%) 3 (3.7%) 5 (3.7%)
霧視 2 (3.7%) 3 (3.7%) 5 (3.7%)
眼のアレルギー 1 (1.9%) 3 (3.7%) 4 (2.9%)
眼脂
点状角膜炎 1 (1.9%) 3 (3.7%) 4 (2.9%)
網膜浮腫 2 (3.7%) 2 (2.4%) 4 (2.9%)
眼瞼皮膚弛緩症 1 (1.9%) 2 (2.4%) 3 (2.2%)
皮質白内障 3 (5.6%) 0 3 (2.2%)
結膜炎 3 (5.6%) 0 3 (2.2%)
眼刺激 0 3 (3.7%) 3 (2.2%)
黄斑浮腫 1 (1.9%) 2 (2.4%) 3 (2.2%)
変視症 1 (1.9%) 2 (2.4%) 3 (2.2%)
光視症 2 (3.7%) 1 (1.2%) 3 (2.2%)
前房内細胞 0 2 (2.4%) 2 (1.5%)
アレルギー性結膜炎 1 (1.9%) 1 (1.2%) 2 (1.5%)
角膜浮腫 1 (1.9%) 1 (1.2%) 2 (1.5%)
糖尿病性網膜症 2 (3.7%) 0 2 (1.5%)
眼瞼外反 0 2 (2.4%) 2 (1.5%)
眼瞼浮腫 0 2 (2.4%) 2 (1.5%)
乾性角結膜炎 2 (3.7%) 0 2 (1.5%)
眼充血 1 (1.9%) 1 (1.2%) 2 (1.5%)
暗点 2 (3.7%) 0 2 (1.5%)
角膜リポイド環 0 1 (1.2%) 1 (0.7%)
アレルギー性眼瞼炎 1 (1.9%) 0 1 (0.7%)
脈絡網膜障害 0 1 (1.2%) 1 (0.7%)
結膜充血 0 1 (1.2%) 1 (0.7%)
結膜浮腫 1 (1.9%) 0 1 (0.7%)
複視 0 1 (1.2%) 1 (0.7%)
眼瞼湿疹 0 1 (1.2%) 1 (0.7%)
眼瞼出血
緑内障 0 1 (1.2%) 1 (0.7%)
星状硝子体症 0 1 (1.2%) 1 (0.7%)
虹彩癒着 1 (1.9%) 0 1 (0.7%)
涙液分泌低下 1 (1.9%) 0 1 (0.7%)
黄斑嚢胞 1 (1.9%) 0 1 (0.7%)
マイボーム腺機能不全 1 (1.9%) 0 1 (0.7%)
高眼圧症 1 (1.9%) 0 1 (0.7%)
視神経障害 0 1 (1.2%) 1 (0.7%)
翼状片 1 (1.9%) 0 1 (0.7%)
網膜血管瘤 0 1 (1.2%) 1 (0.7%)
網膜動脈塞栓症 0 1 (1.2%) 1 (0.7%)
網膜血管新生 0 1 (1.2%) 1 (0.7%)
網膜色素上皮症 0 1 (1.2%) 1 (0.7%)
網膜裂孔 0 1 (1.2%) 1 (0.7%)
硝子体細胞 1 (1.9%) 0 1 (0.7%)
硝子体癒着 0 1 (1.2%) 1 (0.7%)
硝子体変性 0 1 (1.2%) 1 (0.7%)
硝子体混濁 0 1 (1.2%) 1 (0.7%)
全身障害および投与局所様態 0 10 (12.2%) 10 (7.4%)
注射部位疼痛 0 7 (8.5%) 7 (5.1%)
注射部位不快感 0 3 (3.7%) 3 (2.2%)
顔面痛 0 1 (1.2%) 1 (0.7%)
注射部位紅斑
視野検査異常 0 1 (1.2%) 1 (0.7%)
傷害、中毒および処置合併症 1 (1.9%) 5 (6.1%) 6 (4.4%)
角膜擦過傷 0 2 (2.4%) 2 (1.5%)
眼外傷 0 1 (1.2%) 1 (0.7%)
眼の貫通性外傷 0 1 (1.2%) 1 (0.7%)
黄斑部瘢痕 1 (1.9%) 0 1 (0.7%)
過量投与 0 1 (1.2%) 1 (0.7%)
処置後浮腫 0 1 (1.2%) 1 (0.7%)
先天性、家族性および遺伝性障害 3 (5.6%) 1 (1.2%) 4 (2.9%)
角膜ジストロフィー 2 (3.7%) 1 (1.2%) 3 (2.2%)
睫毛重生 1 (1.9%) 0 1 (0.7%)
感染症および寄生虫症 0 2 (2.4%) 2 (1.5%)
眼帯状疱疹 0 1 (1.2%) 1 (0.7%)
麦粒腫 0 1 (1.2%) 1 (0.7%)
皮膚および皮下組織障害 1 (1.9%) 1 (1.2%) 2 (1.5%)
脂漏性皮膚炎 1 (1.9%) 0 1 (0.7%)
顔面腫脹 0 1 (1.2%) 1 (0.7%)
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） 1 (1.9%) 0 1 (0.7) 眼瞼乳頭腫
Note: Cutoff date for the data is 20 .
Note: the tables indicating that the results are presented by the primary system organ class and preferred term and sorted in descending frequency of 'All' column Source: 5.3.5.4-1 702試験のpost-text table 14.3.1/8
先天性、家族性および遺伝性障害 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%) 角膜ジストロフィー 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
眼障害 20 (40.0%) 35 (70.0%) 43 (43.4%) 49 (49.5%) 63 (42.3%) 84 (56.4%)
一過性黒内障 0 0 0 1 (1.0%) 0 1 (0.7%)
前房内細胞 0 1 (2.0%) 0 0 0 1 (0.7%)
前房のフレア 0 0 1 (1.0%) 0 1 (0.7%) 0
角膜リポイド環 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
乱視 0 1 (2.0%) 0 0 0 1 (0.7%)
眼瞼炎 2 (4.0%) 5 (10.0%) 1 (1.0%) 2 (2.0%) 3 (2.0%) 7 (4.7%)
アレルギー性眼瞼炎 0 0 1 (1.0%) 0 1 (0.7%) 0
眼瞼皮膚弛緩症 0 2 (4.0%) 2 (2.0%) 0 2 (1.3%) 2 (1.3%)
白内障 4 (8.0%) 3 (6.0%) 5 (5.1%) 8 (8.1%) 9 (6.0%) 11 (7.4%)
皮質白内障 1 (2.0%) 1 (2.0%) 2 (2.0%) 0 3 (2.0%) 1 (0.7%) 核性白内障 1 (2.0%) 3 (6.0%) 2 (2.0%) 2 (2.0%) 3 (2.0%) 5 (3.4%) 嚢下白内障 0 2 (4.0%) 2 (2.0%) 2 (2.0%) 2 (1.3%) 4 (2.7%) 脈絡膜血管新生 1 (2.0%) 2 (4.0%) 0 2 (2.0%) 1 (0.7%) 4 (2.7%)
結膜濾過胞 0 1 (2.0%) 0 0 0 1 (0.7%)
結膜障害 0 1 (2.0%) 0 0 0 1 (0.7%)
結膜出血 0 5 (10.0%) 3 (3.0%) 4 (4.0%) 3 (2.0%) 9 (6.0%)
結膜炎 1 (2.0%) 1 (2.0%) 1 (1.0%) 1 (1.0%) 2 (1.3%) 2 (1.3%)
アレルギー性結膜炎 0 1 (2.0%) 0 0 0 1 (0.7%)
角膜沈着物 0 2 (4.0%) 0 0 0 2 (1.3%)
角膜浮腫 0 1 (2.0%) 0 2 (2.0%) 0 3 (2.0%)
角膜混濁 0 0 0 1 (1.0%) 0 1 (0.7%)
網膜色素上皮剥離 0 3 (6.0%) 2 (2.0%) 0 2 (1.3%) 3 (2.0%)
糖尿病性網膜症 0 0 0 1 (1.0%) 0 1 (0.7%)
複視 1 (2.0%) 0 1 (1.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
眼乾燥 1 (2.0%) 2 (4.0%) 3 (3.0%) 3 (3.0%) 4 (2.7%) 5 (3.4%)
眼瞼外反 0 0 0 1 (1.0%) 0 1 (0.7%)
眼瞼湿疹 0 0 1 (1.0%) 0 1 (0.7%) 0
眼のアレルギー 0 1 (2.0%) 1 (1.0%) 2 (2.0%) 1 (0.7%) 3 (2.0%)
眼脂 0 1 (2.0%) 1 (1.0%) 0 1 (0.7%) 1 (0.7%)
眼刺激 0 0 1 (1.0%) 0 1 (0.7%) 0
眼痛 1 (2.0%) 1 (2.0%) 3 (3.0%) 2 (2.0%) 4 (2.7%) 3 (2.0%)
眼そう痒症 1 (2.0%) 0 3 (3.0%) 3 (3.0%) 4 (2.7%) 3 (2.0%)
眼部腫脹 0 0 1 (1.0%) 0 1 (0.7%) 0
眼瞼下垂 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
眼の異物感 0 0 0 3 (3.0%) 0 3 (2.0%)
緑内障 0 0 0 1 (1.0%) 0 1 (0.7%)
虹彩癒着 0 0 1 (1.0%) 0 1 (0.7%) 0
虹彩萎縮 0 0 0 1 (1.0%) 0 1 (0.7%)
虹彩炎 0 1 (2.0%) 0 0 0 1 (0.7%)
乾性角結膜炎 0 1 (2.0%) 0 0 0 1 (0.7%)
涙液分泌低下 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
流涙増加 0 0 2 (2.0%) 2 (2.0%) 2 (1.3%) 2 (1.3%)
水晶体脱臼 0 1 (2.0%) 0 0 0 1 (0.7%)
黄斑症 0 0 0 2 (2.0%) 0 2 (1.3%)
マイボーム腺機能不全 0 1 (2.0%) 0 0 0 1 (0.7%)
変視症 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
眼充血 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
高眼圧症 1 (2.0%) 0 0 0 1 (0.7%) 0
視神経乳頭出血 0 0 1 (1.0%) 0 1 (0.7%) 0
羞明 2 (4.0%) 0 0 1 (1.0%) 2 (1.3%) 1 (0.7%)
光視症 0 0 1 (1.0%) 0 1 (0.7%) 0
後嚢部混濁 1 (2.0%) 1 (2.0%) 3 (3.0%) 1 (1.0%) 4 (2.7%) 2 (1.3%)
点状角膜炎 0 2 (4.0%) 0 1 (1.0%) 0 3 (2.0%)
瞳孔変形 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
網膜血管瘤 0 0 0 1 (1.0%) 0 1 (0.7%)
網膜変性 1 (2.0%) 3 (6.0%) 3 (3.0%) 0 4 (2.7%) 3 (2.0%)
網膜滲出物 1 (2.0%) 0 1 (1.0%) 2 (2.0%) 2 (1.3%) 2 (1.3%)
網膜出血 1 (2.0%) 4 (8.0%) 4 (4.0%) 3 (3.0%) 5 (3.4%) 7 (4.7%)
網膜血管新生 1 (2.0%) 0 0 1 (1.0%) 1 (0.7%) 1 (0.7%)
網膜浮腫 0 1 (2.0%) 0 2 (2.0%) 0 3 (2.0%)
網膜色素上皮裂孔 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
網膜色素上皮症 0 0 2 (2.0%) 0 2 (1.3%) 0
網膜静脈閉塞 0 0 0 1 (1.0%) 0 1 (0.7%)
霧視 1 (2.0%) 0 1 (1.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
視力低下 1 (2.0%) 1 (2.0%) 0 6 (6.1%) 1 (0.7%) 7 (4.7%)
硝子体剥離 2 (4.0%) 3 (6.0%) 4 (4.0%) 1 (1.0%) 6 (4.0%) 4 (2.7%)
注射部位そう痒感 0 0 1 (1.0%) 0 1 (0.7%) 0
感染症および寄生虫症 0 0 0 2 (2.0%) 0 2 (1.3%)
細菌性結膜炎 0 0 0 1 (1.0%) 0 1 (0.7%)
麦粒腫 0 0 0 1 (1.0%) 0 1 (0.7%)
傷害、中毒および処置合併症 0 2 (4.0%) 0 1 (1.0%) 0 3 (2.0%)
白内障手術合併症 0 1 (2.0%) 0 0 0 1 (0.7%)
挫傷 0 1 (2.0%) 0 0 0 1 (0.7%)
処置後浮腫 0 0 0 1 (1.0%) 0 1 (0.7%)
臨床検査 1 (2.0%) 1 (2.0%) 1 (1.0%) 1 (1.0%) 2 (1.3%) 2 (1.3%)
眼圧上昇 0 1 (2.0%) 1 (1.0%) 0 1 (0.7%) 1 (0.7%)
視神経乳頭陥凹／乳頭比増加 1 (2.0%) 0 0 1 (1.0%) 1 (0.7%) 1 (0.7%)
瞳孔対光反射試験異常 0 1 (2.0%) 0 0 0 1 (0.7%)
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）
0 1 (2.0%) 1 (1.0%) 0 1 (0.7%) 1 (0.7%)
眼の母斑 0 1 (2.0%) 0 0 0 1 (0.7%)
眼瞼の悪性新生物 0 0 1 (1.0%) 0 1 (0.7%) 0
神経系障害 0 0 1 (1.0%) 0 1 (0.7%) 0
前兆を伴う片頭痛 0 0 1 (1.0%) 0 1 (0.7%) 0
外科および内科処置 0 0 0 1 (1.0%) 0 1 (0.7%)
角膜縫合 0 0 0 1 (1.0%) 0 1 (0.7%)
Note: Cutoff date for the data is 20 . Source: 5.3.5.4-1 702試験のpost-text table 14.3.1/9
黄斑変性 8 (14.8%) 12 (14.6%) 20 (14.7%)
白内障 9 (16.7%) 8 (9.8%) 17 (12.5%)
網膜出血 6 (11.1%) 5 (6.1%) 11 (8.1%)
結膜出血 5 (9.3%) 5 (6.1%) 10 (7.4%)
硝子体剥離 6 (11.1%) 4 (4.9%) 10 (7.4%)
眼乾燥 3 (5.6%) 6 (7.3%) 9 (6.6%)
眼瞼炎 6 (11.1%) 2 (2.4%) 8 (5.9%)
核性白内障 4 (7.4%) 4 (4.9%) 8 (5.9%)
眼痛 2 (3.7%) 5 (6.1%) 7 (5.1%)
視力低下 2 (3.7%) 5 (6.1%) 7 (5.1%)
嚢下白内障 2 (3.7%) 4 (4.9%) 6 (4.4%)
網膜色素上皮剥離 4 (7.4%) 2 (2.4%) 6 (4.4%)
眼そう痒症 1 (1.9%) 5 (6.1%) 6 (4.4%)
網膜変性 3 (5.6%) 3 (3.7%) 6 (4.4%)
硝子体浮遊物 0 6 (7.3%) 6 (4.4%)
脈絡膜血管新生 3 (5.6%) 2 (2.4%) 5 (3.7%)
眼瞼皮膚弛緩症 2 (3.7%) 2 (2.4%) 4 (2.9%)
皮質白内障 3 (5.6%) 1 (1.2%) 4 (2.9%)
眼のアレルギー 1 (1.9%) 3 (3.7%) 4 (2.9%)
流涙増加 0 4 (4.9%) 4 (2.9%)
後嚢部混濁 1 (1.9%) 3 (3.7%) 4 (2.9%)
角膜浮腫 1 (1.9%) 2 (2.4%) 3 (2.2%)
複視 1 (1.9%) 2 (2.4%) 3 (2.2%)
網膜滲出物 1 (1.9%) 2 (2.4%) 3 (2.2%)
網膜浮腫 1 (1.9%) 2 (2.4%) 3 (2.2%)
角膜リポイド環 1 (1.9%) 1 (1.2%) 2 (1.5%)
結膜炎 1 (1.9%) 1 (1.2%) 2 (1.5%)
眼脂 1 (1.9%) 1 (1.2%) 2 (1.5%)
眼瞼下垂 0 2 (2.4%) 2 (1.5%)
涙液分泌低下 1 (1.9%) 1 (1.2%) 2 (1.5%)
黄斑浮腫 0 2 (2.4%) 2 (1.5%)
黄斑症 0 2 (2.4%) 2 (1.5%)
変視症 0 2 (2.4%) 2 (1.5%)
眼充血 0 2 (2.4%) 2 (1.5%)
瞳孔変形 1 (1.9%) 1 (1.2%) 2 (1.5%)
網膜血管新生 1 (1.9%) 1 (1.2%) 2 (1.5%)
網膜色素上皮裂孔 0 2 (2.4%) 2 (1.5%)
網膜色素上皮症 0 2 (2.4%) 2 (1.5%)
霧視 1 (1.9%) 1 (1.2%) 2 (1.5%)
一過性黒内障 0 1 (1.2%) 1 (0.7%)
前房内細胞 1 (1.9%) 0 1 (0.7%)
前房のフレア 1 (1.9%) 0 1 (0.7%)
乱視 1 (1.9%) 0 1 (0.7%)
アレルギー性眼瞼炎 1 (1.9%) 0 1 (0.7%)
結膜濾過胞 1 (1.9%) 0 1 (0.7%)
結膜障害 1 (1.9%) 0 1 (0.7%)
アレルギー性結膜炎 1 (1.9%) 0 1 (0.7%)
角膜沈着物
眼瞼外反 0 1 (1.2%) 1 (0.7%)
眼瞼湿疹 0 1 (1.2%) 1 (0.7%)
眼刺激 0 1 (1.2%) 1 (0.7%)
眼部腫脹 0 1 (1.2%) 1 (0.7%)
緑内障 0 1 (1.2%) 1 (0.7%)
虹彩萎縮 0 1 (1.2%) 1 (0.7%)
虹彩炎 1 (1.9%) 0 1 (0.7%)
乾性角結膜炎 1 (1.9%) 0 1 (0.7%)
水晶体脱臼 1 (1.9%) 0 1 (0.7%)
マイボーム腺機能不全 1 (1.9%) 0 1 (0.7%)
高眼圧症 1 (1.9%) 0 1 (0.7%)
光視症 0 1 (1.2%) 1 (0.7%)
網膜血管瘤 0 1 (1.2%) 1 (0.7%)
網膜静脈閉塞 0 1 (1.2%) 1 (0.7%)
臨床検査 2 (3.7%) 2 (2.4%) 4 (2.9%)
眼圧上昇 1 (1.9%) 1 (1.2%) 2 (1.5%)
視神経乳頭陥凹／乳頭比増加 1 (1.9%) 1 (1.2%) 2 (1.5%)
瞳孔対光反射試験異常 1 (1.9%) 0 1 (0.7%)
傷害、中毒および処置合併症 2 (3.7%) 1 (1.2%) 3 (2.2%)
白内障手術合併症 1 (1.9%) 0 1 (0.7%)
挫傷 1 (1.9%) 0 1 (0.7%)
処置後浮腫
注射部位紅斑 1 (1.9%) 0 1 (0.7%)
注射部位そう痒感 0 1 (1.2%) 1 (0.7%)
感染症および寄生虫症 0 2 (2.4%) 2 (1.5%)
細菌性結膜炎 0 1 (1.2%) 1 (0.7%)
麦粒腫 0 1 (1.2%) 1 (0.7%)
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） 1 (1.9%) 1 (1.2%) 2 (1.5%)
眼の母斑 1 (1.9%) 0 1 (0.7%)
眼瞼の悪性新生物 0 1 (1.2%) 1 (0.7%)
神経系障害 0 1 (1.2%) 1 (0.7%)
前兆を伴う片頭痛 0 1 (1.2%) 1 (0.7%)
皮膚および皮下組織障害 1 (1.9%) 0 1 (0.7%)
脂漏性皮膚炎 1 (1.9%) 0 1 (0.7%)
外科および内科処置 0 1 (1.2%) 1 (0.7%)
角膜縫合 0 1 (1.2%) 1 (0.7%)
Note: Cutoff date for the data is 20 .
Note: the tables indicating that the results are presented by the primary system organ class and preferred term and sorted in descending frequency of 'All' column Source: 5.3.5.4-1 702試験のpost-text table 14.3.1/12
Uncoded 0 1 (2.0%) 0 0 0 1 (0.7%)
Uncoded 0 1 (2.0%) 0 0 0 1 (0.7%)
血液およびリンパ系障害 0 1 (2.0%) 5 (5.1%) 6 (6.1%) 5 (3.4%) 7 (4.7%)
貧血 0 1 (2.0%) 1 (1.0%) 4 (4.0%) 1 (0.7%) 5 (3.4%)
白血球増加症 0 0 1 (1.0%) 3 (3.0%) 1 (0.7%) 3 (2.0%) リンパ節症 0 1 (2.0%) 1 (1.0%) 0 1 (0.7%) 1 (0.7%)
正色素性正球性貧血 0 0 1 (1.0%) 0 1 (0.7%) 0
血小板増加症 0 0 1 (1.0%) 0 1 (0.7%) 0
白血球障害 0 0 1 (1.0%) 0 1 (0.7%) 0
心臓障害 4 (8.0%) 4 (8.0%) 8 (8.1%) 12 (12.1%) 12 (8.1%) 16 (10.7%)
急性心筋梗塞 0 0 0 1 (1.0%) 0 1 (0.7%)
狭心症 1 (2.0%) 0 2 (2.0%) 1 (1.0%) 3 (2.0%) 1 (0.7%)
不安定狭心症 0 0 1 (1.0%) 0 1 (0.7%) 0
不整脈 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
冠動脈硬化症 0 0 2 (2.0%) 0 2 (1.3%) 0
心房細動 1 (2.0%) 2 (4.0%) 1 (1.0%) 2 (2.0%) 2 (1.3%) 4 (2.7%)
房室ブロック 0 0 0 1 (1.0%) 0 1 (0.7%)
第一度房室ブロック 0 0 0 1 (1.0%) 0 1 (0.7%)
徐脈 0 1 (2.0%) 0 0 0 1 (0.7%)
うっ血性心不全 1 (2.0%) 0 1 (1.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
心粗動 0 0 0 1 (1.0%) 0 1 (0.7%)
冠動脈閉塞 0 0 0 1 (1.0%) 0 1 (0.7%) 冠動脈狭窄 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
心筋梗塞 0 0 0 2 (2.0%) 0 2 (1.3%)
動悸 0 0 0 1 (1.0%) 0 1 (0.7%)
心膜炎 1 (2.0%) 0 0 0 1 (0.7%) 0
上室性期外収縮 0 0 1 (1.0%) 0 1 (0.7%) 0
頻脈 0 0 0 1 (1.0%) 0 1 (0.7%)
心室性期外収縮 0 0 1 (1.0%) 0 1 (0.7%) 0
先天性、家族性および遺伝性障害 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
異形成母斑症候群 0 1 (2.0%) 0 0 0 1 (0.7%)
包茎 0 0 0 1 (1.0%) 0 1 (0.7%)
耳および迷路障害 2 (4.0%) 4 (8.0%) 2 (2.0%) 3 (3.0%) 4 (2.7%) 7 (4.7%)
耳そう痒症 0 1 (2.0%) 0 0 0 1 (0.7%)
中耳の炎症 0 1 (2.0%) 0 0 0 1 (0.7%)
乗物酔い 0 0 1 (1.0%) 0 1 (0.7%) 0
鼓膜穿孔 0 0 1 (1.0%) 0 1 (0.7%) 0
回転性めまい 2 (4.0%) 2 (4.0%) 0 3 (3.0%) 2 (1.3%) 5 (3.4%) 内分泌障害 1 (2.0%) 2 (4.0%) 1 (1.0%) 1 (1.0%) 2 (1.3%) 3 (2.0%)
甲状腺腫 0 1 (2.0%) 0 0 0 1 (0.7%)
甲状腺機能低下症 1 (2.0%) 1 (2.0%) 1 (1.0%) 1 (1.0%) 2 (1.3%) 2 (1.3%)
胃腸障害 6 (12.0%) 14 (28.0%) 15 (15.2%) 28 (28.3%) 21 (14.1%) 42 (28.2%) 腹部不快感 1 (2.0%) 1 (2.0%) 0 2 (2.0%) 1 (0.7%) 3 (2.0%)
腹痛 0 0 2 (2.0%) 3 (3.0%) 2 (1.3%) 3 (2.0%)
上腹部痛 0 0 2 (2.0%) 2 (2.0%) 2 (1.3%) 2 (1.3%)
腹部圧痛 0 0 1 (1.0%) 0 1 (0.7%) 0
結腸ポリープ 0 1 (2.0%) 0 2 (2.0%) 0 3 (2.0%)
便秘 0 2 (4.0%) 3 (3.0%) 3 (3.0%) 3 (2.0%) 5 (3.4%)
齲歯 0 1 (2.0%) 1 (1.0%) 2 (2.0%) 1 (0.7%) 3 (2.0%)
下痢 2 (4.0%) 5 (10.0%) 4 (4.0%) 5 (5.1%) 6 (4.0%) 10 (6.7%)
憩室 1 (2.0%) 0 1 (1.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)
穿孔性十二指腸潰瘍 0 1 (2.0%) 0 0 0 1 (0.7%)
消化不良 0 1 (2.0%) 0 3 (3.0%) 0 4 (2.7%)
嚥下障害 1 (2.0%) 2 (4.0%) 0 0 1 (0.7%) 2 (1.3%)
小腸炎 0 0 0 1 (1.0%) 0 1 (0.7%)
おくび 0 0 1 (1.0%) 0 1 (0.7%) 0
鼓腸 0 0 0 1 (1.0%) 0 1 (0.7%)
食中毒 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
胃潰瘍 0 0 0 1 (1.0%) 0 1 (0.7%)
胃炎 0 0 0 2 (2.0%) 0 2 (1.3%)
胃食道逆流性疾患 1 (2.0%) 2 (4.0%) 1 (1.0%) 2 (2.0%) 2 (1.3%) 4 (2.7%)
痔核 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
裂孔ヘルニア 0 1 (2.0%) 1 (1.0%) 1 (1.0%) 1 (0.7%) 2 (1.3%)
口の感覚鈍麻 0 0 0 1 (1.0%) 0 1 (0.7%)
悪心 2 (4.0%) 3 (6.0%) 5 (5.1%) 4 (4.0%) 7 (4.7%) 7 (4.7%)
食道浮腫 1 (2.0%) 0 0 0 1 (0.7%) 0
食道痙攣 0 0 0 1 (1.0%) 0 1 (0.7%)
食道炎 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
口腔内痛 1 (2.0%) 0 0 0 1 (0.7%) 0
肛門周囲痛 0 1 (2.0%) 0 0 0 1 (0.7%)
直腸出血 0 0 0 1 (1.0%) 0 1 (0.7%)
唾液腺結石 0 0 1 (1.0%) 0 1 (0.7%) 0
歯痛 0 0 0 1 (1.0%) 0 1 (0.7%)
嘔吐 1 (2.0%) 4 (8.0%) 1 (1.0%) 1 (1.0%) 2 (1.3%) 5 (3.4%)
全身障害および投与局所様態 0 6 (12.0%) 7 (7.1%) 10 (10.1%) 7 (4.7%) 16 (10.7%)
無力症 0 0 1 (1.0%) 3 (3.0%) 1 (0.7%) 3 (2.0%)
胸痛 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
悪寒 0 1 (2.0%) 0 0 0 1 (0.7%)
死亡 0 1 (2.0%) 0 0 0 1 (0.7%)
疲労 0 0 1 (1.0%) 1 (1.0%) 1 (0.7%) 1 (0.7%)
歩行障害 0 1 (2.0%) 0 1 (1.0%) 0 2 (1.3%)
ヘルニア痛 0 0 1 (1.0%) 0 1 (0.7%) 0
インフルエンザ様疾患 0 0 0 1 (1.0%) 0 1 (0.7%)
注射部位血腫 0 0 0 1 (1.0%) 0 1 (0.7%)
倦怠感 0 0 1 (1.0%) 0 1 (0.7%) 0
化生 0 1 (2.0%) 0 0 0 1 (0.7%)
末梢性浮腫 0 0 2 (2.0%) 1 (1.0%) 2 (1.3%) 1 (0.7%)