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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT00608634
Description: Standard Questionnaire
Frequency Threshold: 5
Time Frame: 3 months for each participant.
Study: NCT00608634
Study Brief: Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. None None 4 28 11 28 View
Low Dose POH 0.3% Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. None None 5 27 14 27 View
High Dose POH 0.76% Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. None None 1 28 15 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SCC in treatment area SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
SCC outside of treatment area SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Stent Replacement SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
BCC outside of treatment area SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Melanoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Rash, Redness, Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View