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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
NCT ID:
NCT02566993
Group ID:
EG001
Title:
Topotecan
Description:
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.
Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
* 1.50 mg/m2 daily, for patients with calculated CrCL ≥60 mL/min.
* 1.25 mg/m2 daily, for patients with calculated CrCL between 40 and 59 mL/min.
* 0.75 mg/m2 daily, for patients with calculated CrCL between 30 and 39 mL/min.
Deaths Number Affected:
100
Deaths Number At Risk:
None
Serious Number Affected:
66
Serious Number At Risk:
121
Other Number Affected:
120
Other Number At Risk:
121
Study:
NCT02566993
Results Section:
NCT02566993
Adverse Events Module:
NCT02566993