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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT02657005
Group ID:
EG010
Title:
175 mg/m^2
Description:
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT02657005
Results Section:
NCT02657005
Adverse Events Module:
NCT02657005