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 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
NCT ID:
NCT00666666
Group ID:
EG000
Title:
AT101 (R-(-)-Gossypol Acetic Acid)
Description:
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
13
Serious Number At Risk:
55
Other Number Affected:
55
Other Number At Risk:
55
Study:
NCT00666666
Results Section:
NCT00666666
Adverse Events Module:
NCT00666666