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 @ 6:58 PM
Ignite Modification Date: 2025-12-25 @ 4:31 PM
NCT ID: NCT02878057
Description: The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.
Frequency Threshold: 3
Time Frame: through study completion, an median of 18 months
Study: NCT02878057
Study Brief: Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Advanced Breast Cancer Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) 2 None 12 30 1 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bilirubin increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Transaminase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection NON_SYSTEMATIC_ASSESSMENT General disorders None View