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 @ 1:58 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
NCT ID:
NCT01614795
Group ID:
EG000
Title:
Group 1 Relapsed or Refractory Osteosarcoma
Description:
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).
temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.
laboratory biomarker analysis: Correlative studies
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT01614795
Results Section:
NCT01614795
Adverse Events Module:
NCT01614795