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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT00668733
Description: All AEs that were ongoing or started in the previous treatment area at the end of Phase 3 study, or any AEs that occurred that were related to the previous Phase 3 study medication were recorded.
Frequency Threshold: 3
Time Frame: 12 months
Study: NCT00668733
Study Brief: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2-Week Treatment Group Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \[EOS\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. None None 0 79 3 89 View
3-Week Treatment Group Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \[EOS\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. None None 0 90 0 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View