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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01140568
Description: used clinicaltrials.gov definitions
Frequency Threshold: 5
Time Frame: 8 years
Study: NCT01140568
Study Brief: Study of Platelet Derived Growth Factor Receptor (PDGFR) in 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
Nilotinib Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects. nilotinib: 400mg po (orally) BID (twice daily) 0 None 3 34 24 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Musculoskeletal tissue disorder-other: Muscle Spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized Muscle Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT Increase SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
AST Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Localized Edema NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Rash Acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View