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 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
NCT ID:
NCT00467051
Group ID:
EG000
Title:
Treatment (Chemotherapy, Biological Therapy)
Description:
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV dosage 135 mg/m2/dose
carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.
ifosfamide: Given IV dosage 1800 mg/m2/dose
filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2
laboratory biomarker analysis: Optional correlative studies
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
20
Other Number Affected:
18
Other Number At Risk:
20
Study:
NCT00467051
Results Section:
NCT00467051
Adverse Events Module:
NCT00467051