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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT01067469
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data collected every six weeks after baseline, up to one year (52 weeks).
Study: NCT01067469
Study Brief: Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Dose Bevacizumab Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle. 6 None 9 36 26 36 View
Low Dose Bevacizumab + Lomustine Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 90 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle. Due to hematologic toxicities, the starting dose was reduced to 75 mg/m2. 1 None 9 35 23 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CNS Ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Vessel injury - artery SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (2.0) View
Muscle weakness - generalized SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (2.0) View
Perforation, GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Mental status change SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Thrombus, embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
CNS Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
ALT/SGPT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
AST/SGOT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
alk phos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View