Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT05923112
Group ID:
EG000
Title:
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
Description:
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
Deaths Number Affected:
21
Deaths Number At Risk:
None
Serious Number Affected:
43
Serious Number At Risk:
136
Other Number Affected:
71
Other Number At Risk:
136
Study:
NCT05923112
Results Section:
NCT05923112
Adverse Events Module:
NCT05923112