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:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
NCT ID:
NCT03275402
Group ID:
EG000
Title:
131I-omburtamab
Description:
One treatment cycle of 131I-omburtamab consists of 1 dose at 50mCi at week 1. For Japan only one treatment cycle of 131I-omburtamab consists of 2 doses: 2mCi at week 1 and 50mCi at week 2. First cycle is initiated right after confirmation of eligibility at week 1. At week 5 (week 6 for Japan) the participant will be evaluated for safety and if eligible, receive a second cycle of 131I-omburtamab.
Secondary efficacy endpoints will be evaluated at week 26 and primary efficacy endpoint will be evaluated at week 156.
131I-omburtamab: Murine IgG1 monoclonal antibody radiolabeled with iodine-131
Deaths Number Affected:
17
Deaths Number At Risk:
None
Serious Number Affected:
20
Serious Number At Risk:
52
Other Number Affected:
49
Other Number At Risk:
52
Study:
NCT03275402
Results Section:
NCT03275402
Adverse Events Module:
NCT03275402