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 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02416908
Group ID:
EG000
Title:
Phase I Schedule A (Selinexor)
Description:
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT02416908
Results Section:
NCT02416908
Adverse Events Module:
NCT02416908