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 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT02116361
Description: The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
Frequency Threshold: 5
Time Frame: None
Study: NCT02116361
Study Brief: OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
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 (Normal Saline) for onabotulinumtoxinA 50 U Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. None None 5 67 21 67 View
Placebo (Normal Saline) for onabotulinumtoxinA 30 U Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. None None 1 58 10 58 View
onabotulinumtoxinA 50 U OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. None None 0 65 18 65 View
onabotulinumtoxinA 30 U OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. None None 3 65 21 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fibula Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 19.1 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 19.1 View
Ligament Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 19.1 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 19.1 View
Varicose Vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 19.1 View
Sudden Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 19.1 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 19.1 View
Hallucination, Auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 19.1 View
Benign Breast Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 19.1 View
Eyelid Ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 19.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.1 View
URI SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.1 View