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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT01194869
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01194869
Study Brief: Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage 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
Sorafenib Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel. None None 6 25 24 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Obstructive Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pulmonary Embolus NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acute Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hand-Foot Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View