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 @ 11:51 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT00525161
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00525161
Study Brief: Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced 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 & Endocrine Therapy Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first. None None 2 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection/Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Weight Loss NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Stevens-Johnson Syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Nausea/vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Elevated ALT/AST NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Joint Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View