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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT01310868
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01310868
Study Brief: Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
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-ALA and Gliadel Wafers This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM. 5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection. None None 26 59 23 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cerebral spinal fluid leak SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
psychiatric disorders - other (steroid induced aggression) SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
other - bowel perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intra-abdomial hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
muscle weakness left sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
infection - cerebral abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
infections other (not specified) SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
thrombolytic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
white blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
wound infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View