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 @ 3:00 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT01440959
Description: None
Frequency Threshold: 5
Time Frame: Up to 3 years
Study: NCT01440959
Study Brief: Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TKI258 dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule None None 8 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders NCI_CTCAE version 3. View
QT prolongation SYSTEMATIC_ASSESSMENT Cardiac disorders NCI_CTCAE version 3. View
Plumonary thromboembolism SYSTEMATIC_ASSESSMENT Cardiac disorders NCI_CTCAE version 3. View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI_CTCAE version 3. View
Azotemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI_CTCAE version 3. View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders NCI_CTCAE version 3. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI_CTCAE version 3. View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI_CTCAE version 3. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders NCI_CTCAE version 3. View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI_CTCAE version 3. View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI_CTCAE version 3. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCI_CTCAE version 3. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Elevated aspartate aminotransferase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI_CTCAE version 3. View
Elevated alanine transaminase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI_CTCAE version 3. View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI_CTCAE version 3. View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI_CTCAE version 3. View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders NCI_CTCAE version 3. View
Azotemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI_CTCAE version 3. View