Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT04068168
Brief Summary:
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Detailed Description:
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
* Dose interruptions
* Duration of treatment
* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
* Progression free survival (PFS)
* Objective response rate (ORR)
* Duration of response (DoR)
Study:
NCT04068168
Study Brief:
Protocol Section:
NCT04068168