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 @ 9:48 PM
Ignite Modification Date: 2025-12-25 @ 7:27 PM
NCT ID: NCT02004132
Description: Events deemed to be serious adverse events (SAEs) by the Investigator as related to study drug administration were collected during the study and up to 9 days following study drug administration.
Frequency Threshold: 5
Time Frame: Randomization up to 9 days follow-up
Study: NCT02004132
Study Brief: A Study of Axiron® 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
Axiron 120 mg Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. None None 0 12 2 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View