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 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
NCT ID:
NCT01889420
Group ID:
EG000
Title:
Combination Therapy
Description:
Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle
Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
Cycles will span 28 days. Dosage schedules will be:
1. Everolimus daily for 28 days of a 28 day cycle;
2. Pomalidomide daily for 21 days of a 28 day cycle
3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
1
Other Number Affected:
1
Other Number At Risk:
1
Study:
NCT01889420
Results Section:
NCT01889420
Adverse Events Module:
NCT01889420