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: 2025-12-24 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT00400569
Description: None
Frequency Threshold: 5
Time Frame: 4 years, 7 months
Study: NCT00400569
Study Brief: Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Sunitinib Malate (SU011248) Treatment Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks None None 13 48 39 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver dysfunction/failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTC V3 View
Pain - Abdomen SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Death not associated with CTCAE term - Disease progression SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Infection with unknown ANC - Peritoneal cavity SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Cardiac general SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Hemorrhate/Bleeding SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC V3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Dysguesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Hemorrhage/bleeding SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View