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:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:36 AM
NCT ID:
NCT02517918
Group ID:
EG002
Title:
Expansion Cohort With Dose Sirolimus (SI) 4 mg
Description:
Prospective open-labeled phase I trial. The expansion cohort is designed to enable to detect antitumor activity observed with sirolimus (SI) combined with cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA).
Sirolimus (SI) dose 4 mg when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) Sirolimus will be administered per os once daily, continuously. One cycle consits of 28 days.
Number of subjects : 14. Cyclophosphamide will be administered per os bi-daily (50 mg x 2), and given on a week on/week off schedule.
Methotrexate will be administered per os bi-daily (2.5 mg x 2), and given on day 1 and 4 every week.
Zoledronic acid will be administered at home by intravenous infusion (4 mg) on Day 2 of each cycle, every 4 weeks.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
14
Other Number Affected:
14
Other Number At Risk:
14
Study:
NCT02517918
Results Section:
NCT02517918
Adverse Events Module:
NCT02517918