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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT01399866
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01399866
Study Brief: Cognitive Remediation With D-Cycloserine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
D-cycloserine 50 mg capsule,single dose, twice, one week apart, by mouth D-cycloserine: 2 single weekly doses, 50 mg capsule None None 0 30 24 30 View
Placebo 50 mg capsule,single dose, twice, one week apart, by mouth Placebo None None 1 32 24 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
compression fracture None Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia None General disorders None View
Blurred vision None General disorders None View
Depressen mood None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry mouth None General disorders None View
Fever None General disorders None View
Headache None General disorders None View
Insomnia None General disorders None View
Malaise None General disorders None View
Nausea None Gastrointestinal disorders None View
Restlessness None Psychiatric disorders None View
Drowsiness None General disorders None View
Stiffness None General disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Other None General disorders None View
Hypersalivation None General disorders None View
Irritability None Psychiatric disorders None View
Constipation None Gastrointestinal disorders None View
Dizziness None General disorders None View
Enuresis None General disorders None View
Skin rash None Skin and subcutaneous tissue disorders None View
Sore throat None Respiratory, thoracic and mediastinal disorders None View
Vomiting None Gastrointestinal disorders None View