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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT00706433
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00706433
Study Brief: Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALA 1000 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) None None 0 68 35 None View
ALA 500 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) None None 0 65 38 None View
Vehicle 500 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) None None 0 66 22 None View
Vehicle 1000 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) None None 0 67 19 None View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Stinging/Burning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dry skin SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Itching of face SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scabbing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Peeling of skin SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tightness of skin SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Facial Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View