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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT00420004
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00420004
Study Brief: A Study for Participants With Major Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LY2216684 Double Blind Phase LY2216684: 3, 6, 9, or 12 milligrams (mg) tablets, administered orally with flexible dosing, once daily for 8 weeks None None 2 269 70 269 View
Placebo Double Blind Phase Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally once daily for 8 weeks None None 1 138 26 138 View
Escitalopram Double Blind Phase Escitalopram: 10 or 20 mg capsules, administered orally with flexible dosing, once daily for 8 weeks None None 2 62 19 62 View
LY2216684 Discontinuation Phase Included all randomized participants who discontinued LY2216684 treatment None None 0 269 3 269 View
Placebo Discontinuation Phase Included all randomized participants who discontinued placebo None None 1 138 2 138 View
Escitalopram Discontinuation Phase Included all randomized participants who discontinued escitalopram treatment None None 0 62 2 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Near drowning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View