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 @ 5:45 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT02092168
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02092168
Study Brief: Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
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 30 mg (Once Daily) - Elderly Subjects BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. BIA 9-1067 30 mg (once daily) - Elderly Subjects None None 0 12 2 12 View
BIA 9-1067 30 mg (Once Daily) - Young Subjects BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. BIA 9-1067 30 mg (once daily) - Young Subjects None None 0 12 2 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza like illness None General disorders MedDRA View
Bronchitis lymphangitis None Infections and infestations MedDRA View
Headache None Nervous system disorders MedDRA View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders MedDRA View
Pruritus None Skin and subcutaneous tissue disorders MedDRA View