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: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT02547233
Description: Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
Frequency Threshold: 2
Time Frame: Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Study: NCT02547233
Study Brief: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle Gel - Treatment Period Including Follow-up Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel None None 0 100 3 100 View
LEO 43204 0.018% Gel - Extended Follow-up Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel None None 0 199 23 199 View
Vehicle Gel - Extended Follow-up Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel None None 0 84 3 84 View
LEO 43204 0.018% Gel - Treatment Period Including Follow-up Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel None None 2 205 134 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.1) View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.1) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.1) View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Periorbital oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.1) View
Application site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Application site paraesthesia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Scar NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.1) View
Squamous cell carcinoma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.1) View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.1) View