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: 2025-12-24 @ 1:20 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT02866695
Description: CTC Adverse Events Grading Criteria version 4.0 was used to define adverse events
Frequency Threshold: 5
Time Frame: Each participant was assessed for 57 days from the start of treatment.
Study: NCT02866695
Study Brief: Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Treatment A total of 20 solid organ transplant recipients with 4 to 20 actinic keratoses were enrolled and treated for 3 consecutive days with 4 single-dose tubes of ingenol mebutate gel 0.015% applied to a 100 cm2 area of the face according to study protocol. There was no placebo or comparator for this study. All but 2 participants completed the treatment. One kidney transplant participant forgot to apply the treatment on day 3, but continued in the study. One lung transplant participant who reported pain in the treatment area withdrew from the study after day 2 dosing due to travel considerations and was lost to follow-up. 0 None 5 20 10 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urosepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View