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: 2025-12-25 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT00324805
Description: One patient who did not start treatment submitted an adverse event report
Frequency Threshold: 5
Time Frame: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Study: NCT00324805
Study Brief: Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Chemotherapy) Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV None None 424 738 474 738 View
Arm II (Chemotherapy, Bevacizumab) Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV None None 563 735 509 735 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colonic perforation 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
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Ileus 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
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Autoimmune disorder SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Serum sickness SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Esophageal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
Wound dehiscence 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
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
INR increased 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
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypokalemia 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
Hypophosphatemia 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
Bone 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
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
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Neuralgia 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
Reversible posterior leukoencephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Nervous system disorders - Other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Bronchopleural fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Cough 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
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Respiratory thoracic mediastinal - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary 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
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 4.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Peripheral ischemia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 4.0 View
Duodenal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 4.0 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 4.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Creatinine increased 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
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View