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: 2025-12-25 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:04 AM
NCT ID: NCT00589420
Description: None
Frequency Threshold: 0
Time Frame: first treatment through study completion, approximately 12 months
Study: NCT00589420
Study Brief: Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase II Trial of Sorafenib and Docetaxel All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate None None 0 17 17 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
diarreha SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hand-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View