Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:20 PM
NCT ID: NCT01432457
Description: The same event may appear as both an adverse event (AE) and a serious adverse event (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: NCT01432457
Study Brief: Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
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 100 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. None None 2 309 163 309 View
Placebo Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. None None 6 300 110 300 View
DVS SR 50 mg Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. None None 2 300 159 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Lymphadenopathy View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders Atrial fibrillation View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Constipation View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders Hyperthermia View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Intentional overdose View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Lower limb fracture View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations Abnormal ECG View
Serum serotonin increased SYSTEMATIC_ASSESSMENT Investigations Significantly elevat View
Motor dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders Impaired motor View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders Abnormal behavior View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders Increased depressive View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders Suicidal ideation View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Constipation View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Diarrhoea View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Dry mouth View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Nausea View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Fatigue View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Decreased appetite View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders Dizziness View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Headache View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders Daytime drowsiness View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders Insomnia View