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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT01303406
Group ID:
EG000
Title:
Placebo
Description:
Following the body weight, patients will be allocated to one of the following regimen:
Placebo Patients \< 45 kg - 3 tablets 3 times a day with meals
Placebo Patients \> 45 kg - 5 tablets 3 times a day with meals
Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
13
Other Number Affected:
9
Other Number At Risk:
13
Study:
NCT01303406
Results Section:
NCT01303406
Adverse Events Module:
NCT01303406