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 @ 3:48 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT03039192
Description: Safety analysis set included all randomized participants who received at least 1 dose of study agent in the double-blind treatment phase.
Frequency Threshold: 5
Time Frame: Up to Day 25
Study: NCT03039192
Study Brief: 54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Plus SOC Antidepressant Treatment Subjects self-administered placebo matched to esketamine intranasally (1 spray of placebo to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received standard of care (SOC) antidepressant treatment which was initiated or optimized on Day 1 during double blind phase (DB). 0 None 6 112 66 112 View
Esketamine 84 mg Plus SOC Antidepressant Treatment Subjects self-administered esketamine 84 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) twice per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25) plus received SOC antidepressant treatment which was initiated or optimized on Day 1 during double blind phase. 0 None 4 113 91 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 21.1 View
Diabetic Ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 21.1 View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Depression Suicidal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Suicide Attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 21.1 View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.1 View
Blood Pressure Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Dizziness Postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Dissociation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.1 View