Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT01767792
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data collected for 2 years
Study: NCT01767792
Study Brief: Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bevacizumab Safety and tolerability of bevacizumab for 2 years. Change in hearing response will also be monitored. 0 None 1 22 22 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.3 View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.3 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.3 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.3 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.3 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.3 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.3 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.3 View
AST increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.3 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.3 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.3 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.3 View