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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:11 PM
NCT ID: NCT00782756
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT00782756
Study Brief: Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RT, With Temozolomide and Bevacizumab This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach. 40 None 19 40 40 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Glomerular filtration rate SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage, CNS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection, other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle weakness - Left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Investigations None View
Ocular/Visual - Other (specify) SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain - Back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain - Head/headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Personality/behavioral SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Pyramidal tract dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Speech impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vasovagal episode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhage/Bleeding - other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatology/Skin, other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Investigations None View
Neuropathy - sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain - Joint SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemorrhage, Nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemorrhage, Oral cavity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Investigations None View
Pain - neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary frequency/urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vision-blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Wound complication, non-infectious SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View