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: 2025-12-24 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT04269395
Description: Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses.
Frequency Threshold: 0
Time Frame: From start of study drug administration up to Week 54
Study: NCT04269395
Study Brief: A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MAL Cream Arm Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group (MAL), continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. 0 None 0 87 22 87 View
Vehicle Cream Arm Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. 0 None 0 38 11 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Actinic Keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 22.0 View
Androgenetic Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 22.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 22.0 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 22.0 View
Application site erythema NON_SYSTEMATIC_ASSESSMENT General disorders 22.0 View
Application site atrophy NON_SYSTEMATIC_ASSESSMENT General disorders 22.0 View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders 22.0 View
Corona virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations 22.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 22.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations 22.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 22.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 22.0 View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 22.0 View
Skin papilloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 22.0 View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 22.0 View
Squamous cell carcinoma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 22.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 22.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 22.0 View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 22.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 22.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 22.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders 22.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 22.0 View
Breast mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 22.0 View