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 @ 1:36 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT01462695
Description: One stratum A patient did not receive any study drug and was excluded from the summary of adverse events. SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs) or grade 5 adverse events resulting in death. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Frequency Threshold: 0
Time Frame: None
Study: NCT01462695
Study Brief: Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stratum B: Recurrent Ependymoma Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. None None 9 13 6 13 View
Stratum A: Recurrent High Grade Glioma Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies None None 14 16 8 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS None General disorders None View
Gait disturbance None General disorders None View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dysarthria None Nervous system disorders None View
Facial nerve disorder None Nervous system disorders None View
Headache None Nervous system disorders None View
Hydrocephalus None Nervous system disorders None View
Intracranial hemorrhage None Nervous system disorders None View
Paresthesia None Nervous system disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Seizure None Nervous system disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Fatigue None General disorders None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Lipase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Serum amylase increased None Investigations None View
White blood cell decreased None Investigations None View
Muscle weakness left-sided None Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb None Musculoskeletal and connective tissue disorders None View
Muscle weakness right-sided None Musculoskeletal and connective tissue disorders None View
Paresthesia None Nervous system disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Skin and subcutaneous tissue disorders - Other None Skin and subcutaneous tissue disorders None View