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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT04123704
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Study: NCT04123704
Study Brief: Sitravatinib in Metastatic Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitravatinib Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule 2 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5.0 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v5.0 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v5.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5.0 View
Thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v5.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v5.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v5.0 View