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 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
NCT ID:
NCT01596751
Group ID:
EG007
Title:
Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Description:
Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.
Lead-in phase treatment:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.
Treatment given in each 21 day cycle:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
14
Serious Number At Risk:
22
Other Number Affected:
22
Other Number At Risk:
22
Study:
NCT01596751
Results Section:
NCT01596751
Adverse Events Module:
NCT01596751