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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT00798603
Description: None
Frequency Threshold: 0
Time Frame: 2.5 years
Study: NCT00798603
Study Brief: Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung 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
Pemetrexed + Carboplatin + Bevacizumab Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. None None 10 62 62 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEV4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEV4.0 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEV4.0 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEV4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Wolff-Parkinson-White syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEV4.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEV4.0 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders CTCAEV4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Jejunal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEV4.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAEV4.0 View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEV4.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEV4.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEV4.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEV4.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEV4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAEV4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEV4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEV4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Leukoencephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEV4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEV4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEV4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEV4.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEV4.0 View
Protein urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEV4.0 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Bronchial hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Hiccough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Pharyngeal examination abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEV4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEV4.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEV4.0 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEV4.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEV4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEV4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEV4.0 View
Peripheral ischemia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEV4.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEV4.0 View