表2.7.4.7-12 重篤な有害事象の一覧表(ono-453815試験)- ニボ …€¦ ·...
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![Page 1: 表2.7.4.7-12 重篤な有害事象の一覧表(ONO-453815試験)- ニボ …€¦ · Hyponatremia [低ナトリウム血症] 111 115 Grade 1 Grade 4 Serious③ Interruption Sodium](https://reader033.vdocuments.site/reader033/viewer/2022060403/5f0ebcbc7e708231d440b140/html5/thumbnails/1.jpg)
2.7.4 臨床的安全性
ニボルマ
ブ(
cHL)
205
表 2.7.4.7-12 重篤な有害事象の一覧表(ONO-4538-15 試験) 解析対象集団:SAF
*:①Results in death ②Is life-threatening ③Requires inpatient hospitalization or results in prolongation of existing hospitalization ④Results in persistent or significant disability/incapacity ⑤Results in a congenital anomaly or birth defect ⑥Occurrence of new cancer ⑦Other medically important events 事象名:MedDRA/J ver18.1
被験者
識別コード
性別・
年齢
有害事象名(医師記載)
[MedDRA基本語]
発現時期
[投与開始
●日目] 程度 重篤度*
治験薬の投与
継続の判断 処置
治験薬との
因果関係 経過 持続期間
4162-001 Male
75
Hyponatremia
[低ナトリウム血症]
111
115
Grade 1
Grade 4
Serious③ Interruption Sodium chloride
3% Sodium chloride
Metoclopramide
Serenace
Atarax-P
Risperdal
Primperan
Related Recovered/Resolved 62日間
4162-001 Male
75
Interstitial pneumonia
[間質性肺疾患]
129 Grade 3 Serious③ Withdrawal Methylprednisolone
Prednisolone
Oxygen administration
Related Recovering/Resolving 53日間
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