アファチニブの長期観察PMS

基本情報

NCT ID

NCT02131259

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

1,605

治験依頼者名

Boehringer Ingelheim

概要

In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

対象疾患

介入

依頼者（Sponsor）