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 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
NCT ID:
NCT01817751
Group ID:
EG000
Title:
Treatment (Sorafenib Tosylate, Valproic Acid, Sildenafil)
Description:
* Sorafenib 400 mg orally twice a day;
* Valproic acid (to levels ≥ Lower Level of Normal (LLN) orally twice a day;
* Sildenafil 50 mg orally twice a day
A cycle consists of 4 weeks.
\*The first 6 patients evaluable for qualifying toxicity assessment will be treated as a safety lead-in; enrollment will be gated (the first 3 evaluable patients must complete 4 weeks of the combination therapy before the next 3 patients start combination treatment on protocol)
sorafenib tosylate: Given by mouth
valproic acid: Given by mouth
sildenafil citrate: Given by mouth
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
17
Serious Number At Risk:
47
Other Number Affected:
47
Other Number At Risk:
47
Study:
NCT01817751
Results Section:
NCT01817751
Adverse Events Module:
NCT01817751