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 @ 1:57 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT00586495
Description: Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
Frequency Threshold: 5
Time Frame: None
Study: NCT00586495
Study Brief: Long-term Extension From RCC Phase II (11515)
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 (Nexavar, BAY43-9006) Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally None None 34 95 95 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Prolonged QTC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Cardiac ischemia/infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Left ventricular systolic dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Constitutional symptoms - other NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Death not associated with CTCAE term, death NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Death not associated with CTCAE term, disease progression NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
GI - other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Ulcer, GI, duodeum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Hemorrhage pulmonary, bronchus NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC v.3.0 View
Hemorrhage, GI, colon NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC v.3.0 View
Hemorrhage, GI, duodenum NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC v.3.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC v.3.0 View
Liver dysfunction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTC v.3.0 View
Infection - other NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Infection with normal ANC, bronchus NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Infection with normal ANC, lung (pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Infection with normal ANC, upper airway NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Edema: limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Lymphatics - other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
ALT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Amylase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
AST NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Bilirubin (hyperbilirubinemia) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
CPK NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
GGT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Lipase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Metabolic/lab - other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC v.3.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC v.3.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC v.3.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders NCI CTC v.3.0 View
No code in CTCAE NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, abdomen NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, tumor pain NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Dyspnea (shortness of breath) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Pulmonary - other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Syndromes - other NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders NCI CTC v.3.0 View
Auditory/ear - other NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTC v.3.0 View
Blood - other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTC v.3.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Rigors/chills NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Dermatology - other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Hand-foot skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Rash/desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC v.3.0 View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTC v.3.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
GI - other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Mucositis (clinical exam), oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Mucositis (functional/symptomatic), oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Periodontal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC v.3.0 View
Hemorrhage pulmonary, bronchopulmonary NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC v.3.0 View
Hemorrhage pulmonary, nose NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC v.3.0 View
Infection - other NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Infection with normal ANC, Bronchus NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Infection with normal ANC, Lung (Pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTC v.3.0 View
Edema: head and neck NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Edema: limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC v.3.0 View
Alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
ALT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Amylase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
AST NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Bilirubin (hyperbilirubinemia) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
GGT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Lipase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Metabolic/lab - other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTC v.3.0 View
Musculoskeletal - other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTC v.3.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC v.3.0 View
Neuropathy - sensory NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTC v.3.0 View
Ocular surface disease NON_SYSTEMATIC_ASSESSMENT Eye disorders NCI CTC v.3.0 View
Pain, abdomen NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, back NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, chest/thorax NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, dental/teeth/peridontal NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, extremity/limb NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, head/headache NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, joint NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, other NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, stomach NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, throat/pharynx/larynx NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Pain, tumor pain NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Dyspnea (shortness of breath) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Pulmonary - other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Voice changes NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC v.3.0 View
Flu-like syndrome NON_SYSTEMATIC_ASSESSMENT General disorders NCI CTC v.3.0 View