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 @ 12:01 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT01116661
Description: None
Frequency Threshold: 0
Time Frame: From time of ALA dosing up to 14 days post- operative
Study: NCT01116661
Study Brief: Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5- Aminolevuline Acid Given to HGG Participants 5-Aminolevuline Acid: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery 59 None 12 199 25 199 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Infection - with Grade 3 or 4 nuetrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection - other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
thrombosis/embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Vascular - other SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dermatology/skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Flushing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
ALT,SGPT increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hemoglobin decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pain - skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
metabolic/Laboratory - other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
AST,SGOT increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View