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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT01725451
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT01725451
Study Brief: A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Testosterone Unshaved No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla. None None 0 29 3 29 View
Testosterone Unshaved + Deodorant Spray Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. None None 0 29 1 29 View
Testosterone Unshaved + Deodorant Antiperspirant Spray Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. None None 0 29 2 29 View
Testosterone Unshaved + Deodorant Antiperspirant Stick Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. None None 0 28 4 28 View
Testosterone Shaved No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla. None None 0 26 0 26 View
Testosterone Shaved + Deodorant Antiperspirant Spray Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution. None None 0 26 0 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View