Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01536366
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01536366
Study Brief: Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIA 9-1067 + Repaglinide BIA 9-1067 25 mg Repaglinide 0.5 mg None None 0 24 7 24 View
Repaglinide Repaglinide 0.5 mg None None 0 27 8 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Presyncope None Cardiac disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Influenza like illness None General disorders None View
Cystitis None Infections and infestations None View
Oral herpes None Infections and infestations None View
Otitis externa None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Vulvovaginal candidiasis None Infections and infestations None View
Fall None Injury, poisoning and procedural complications None View
Foot fracture None Injury, poisoning and procedural complications None View
Joint injury None Injury, poisoning and procedural complications None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Blood creatine phosphokinase increased None Investigations None View
Headache None Nervous system disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Hypotension None Vascular disorders None View
Orthostatic hypotension None Vascular disorders None View