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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT00387335
Description: Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Frequency Threshold: 5
Time Frame: Up to two years
Study: NCT00387335
Study Brief: Sunitinib in Treating Patients With Recurrent and/or Metastatic 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
Sunitinib -- Cohort A Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1. None None 3 15 14 15 View
Sunitinib -- Cohort B Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2. None None 1 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sudden death from sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sudden cardiac death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pulmonary hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tumor hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema: head and neck NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Esophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hand-and-foot syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
INR increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oral hemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oral pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neck soft tissue necrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash desquamating NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sinus pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Taste alteration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Trismus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View