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 @ 2:33 PM
Ignite Modification Date: 2025-12-25 @ 1:06 PM
NCT ID: NCT02978859
Description: None
Frequency Threshold: 5
Time Frame: Up to 33 months
Study: NCT02978859
Study Brief: Sitravatinib in Advanced Liposarcoma and Other Soft Tissue 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
MGCD516 Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases. 21 None 12 29 17 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension (Grade 3 and 4) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue (Grade 3) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anemia (Grade 3) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Weight loss (Grade 3) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oral mucositis (Grade 3) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension (Grades 1 and 2) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia (Grade 1 and 2) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Palmar-plantar erythrodysesthesia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight loss (Grade 1 and 2) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oral mucositis (Grades 1 and 2) NON_SYSTEMATIC_ASSESSMENT General disorders None View