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:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
NCT ID:
NCT01658904
Group ID:
EG000
Title:
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
Description:
Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)
•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:
Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2
Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9
Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
3
Other Number Affected:
1
Other Number At Risk:
3
Study:
NCT01658904
Results Section:
NCT01658904
Adverse Events Module:
NCT01658904