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 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
NCT ID:
NCT06358820
Group ID:
EG000
Title:
Adverse Event
Description:
Adverse Event (AE) refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug. Adverse events include the following situations:
Adverse Reaction (AR) related to the investigational drug: refers to any harmful medical event caused by the pharmacological effects or other reasons of the investigational drug under normal usage conditions.
Adverse events unrelated to the investigational drug: Refers to any harmful medical event that occurs during a clinical trial, but is scientifically determined to have no causal relationship with the investigational drug.
Serious Adverse Event (SAE): refers to any harmful medical event that occurs during a clinical trial, regardless of whether it is causally related to the investigational drug, resulting in one of the following consequences:
Causing death; Endangering life (i.e., if not intervened in a timely manner, it may lead to death); Need for hospitalization or extended hospitalization; Causing persistent or significant disability or functional impairment; Causing congenital malformations or birth defects; Significant medical interventions (such as surgery, blood transfusions, etc.) are required.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
31
Serious Number At Risk:
149
Other Number Affected:
3
Other Number At Risk:
149
Study:
NCT06358820
Results Section:
NCT06358820
Adverse Events Module:
NCT06358820