Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00815295
Description: The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
Frequency Threshold: 0
Time Frame: None
Study: NCT00815295
Study Brief: Study of Sorafenib/Cetuximab in Head and Neck 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
Phase 1 - Dose Level 2 Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily. None None 1 8 8 8 View
Phase 1 - Dose Level 1 Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily. None None 1 8 8 8 View
Phase 2 Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I. None None 5 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Tracheostomy site bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pharyngeal fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Nail loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Ear and labyrinth disorders - Other, specify SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View