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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT03142451
Description: None
Frequency Threshold: 2
Time Frame: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Study: NCT03142451
Study Brief: A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FMX103 1.5% Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. 0 None 2 494 4 494 View
Vehicle Foam Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed. 1 None 3 256 5 256 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, Version 20.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, Version 20.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, Version 20.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, Version 20.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, Version 20.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, Version 20.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA, Version 20.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, Version 20.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, Version 20.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA, Version 20.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, Version 20.0 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA, Version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, Version 20.0 View