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 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00940992
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT00940992
Study Brief: A Study of DER 45-EV Gel to Treat 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
DER 45 EV Gel, 1% DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks DER 45 EV: Topical application to face for 12 weeks None None 0 32 7 32 View
Vehicle Placebo Gel applied topically once a day for 12 weeks Vehicle: Topical application to face for 12 weeks None None 0 30 11 30 View
DER 45 EV Gel, 5% DER 45 EV Gel, 5% applied topically once a day for 12 weeks DER 45 EV: Topical application to face for 12 weeks None None 0 30 7 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Application site reaction SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA Version 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA Version 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA Version 14.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedRA Version 14.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA Version 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA Version 14.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA Version 14.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA Version 14.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedRA Version 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA Version 14.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA Version 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA Version 14.0 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA Version 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA Version 14.0 View