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: 2025-12-25 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT02385318
Description: None
Frequency Threshold: 5
Time Frame: 57 days
Study: NCT02385318
Study Brief: To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product Ingenol Mebutate Ingenol Mebutate (Perrigo) 1 None 4 204 11 204 View
Reference Product Ingenol Mebutate Ingenol Mebutate (Reference) 0 None 1 210 14 210 View
Placebo Product Placebo gel Placebo gel 0 None 1 105 0 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Left Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Worsening of Right Hip Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute Gastroenteritis/Food Poisoning NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute Sigmoid Diverticulitis/Colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sudden Death, Probable Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
APPLICATION SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders None View
APPLICATION SITE Pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None View