Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544629
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Imjudo Imfinzi PMS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Imjudo Imfinzi Post-Marketing Surveillance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Based on the re-review of new drugs article Korean pharmaceutical act the objectives of this study are to assess safety and effectiveness of the study drugsImjudo Imfinzi in a real world setting in patients who treated according to the approved indications in Korea
Detailed Description:
Primary Objective
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Secondary Objective
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Exploratory Objective
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Secondary Objective
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Exploratory Objective
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None