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: 2025-12-25 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT00569660
Description: None
Frequency Threshold: 5
Time Frame: 2 years 9 months
Study: NCT00569660
Study Brief: Ph II Study of Azacitidine in Myelofibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Azacitidine 75 mg/m\^2 Subcutaneous daily for 7 days every 4 weeks None None 17 34 10 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection soft tissue SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
CNS Cerebrovascular Ischema SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Non-Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Neurology Intracranial Bleed SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Skin Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Neutropenia Without Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Septic Arthritis Knee SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Bladder Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Superficial Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hemorrhage Post Surgical SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Aortic Aneurism SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Urosepsis Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Infection Laceration Knee SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Gastrointestinal Infections SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Hyperuricemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View