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 @ 7:10 PM
Ignite Modification Date: 2025-12-25 @ 4:44 PM
NCT ID: NCT00775203
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks (plus an additional 30 days for SAEs only)
Study: NCT00775203
Study Brief: A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trazodone Contramid OAD Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability. None None 4 202 168 202 View
Placebo Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD. None None 2 204 122 204 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.0) View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Viral pericarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (8.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (8.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (8.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (8.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (8.0) View