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: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT00474994
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00474994
Study Brief: Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas None None 9 53 37 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death not associated with CTCAE term- Death NOS SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Death not associated with CTCAE term-Disease progression NOS SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-3.0 View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-3.0 View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-3.0 View
Ulcer, Duodenum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
AST, SGOT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Bilirubin (hyperbilirubinemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Gastrointestinal, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-3.0 View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Mucositis (Clincal exam)- Oral cavity SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Rash: hand-foot skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC-3.0 View