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 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
NCT ID:
NCT01098266
Group ID:
EG001
Title:
B: Placebo+BIC
Description:
Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Deaths Number Affected:
13
Deaths Number At Risk:
None
Serious Number Affected:
54
Serious Number At Risk:
193
Other Number Affected:
185
Other Number At Risk:
193
Study:
NCT01098266
Results Section:
NCT01098266
Adverse Events Module:
NCT01098266