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 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
NCT ID:
NCT04648033
Group ID:
EG002
Title:
Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT
Description:
Atovaquone:
* Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy.
* One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date.
* Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).
* Last dose atovaquone taken on the last day of radiotherapy.
* Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason.
Chemotherapy:
* 2 x 21-day cycles.
* 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy.
* 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy.
Radiotherapy:
* 66 Gy in 33 fractions.
* Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
1
Other Number Affected:
1
Other Number At Risk:
1
Study:
NCT04648033
Results Section:
NCT04648033
Adverse Events Module:
NCT04648033