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 @ 4:58 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT01017250
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01017250
Study Brief: Radiosurgery and Avastin for Recurrent Malignant Gliomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stereotactic Radiosurgery Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS). SRS is None None 1 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nail loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View