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: 2025-12-25 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT00384033
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT00384033
Study Brief: Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of 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
DVS SR 50 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). None None 2 148 134 148 View
DVS SR 100 mg DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). None None 2 150 134 150 View
Duloxetine 60 mg Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week). None None 1 157 141 157 View
Placebo Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week). None None 2 161 129 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental injury NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Back pain NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Flu syndrome NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Infection NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Withdrawal syndrome NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Sweating NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART View
Abnormal vision NON_SYSTEMATIC_ASSESSMENT General disorders COSTART View