Adverse Events Module

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 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00022659
Description: None
Frequency Threshold: 0
Time Frame: All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) up to 5 years after stopping study treatment
Study: NCT00022659
Study Brief: Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal 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
Bevacizumab Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy None None 26 62 62 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Edema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Thrombosis Embolism NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Partial Thromboplastin Time NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Weight Gain(No Vod) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Gi Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pain Tumor NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Hematologic Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Ischemia/Cardiac Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Melena/Gi Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Voice Changes/Stridor/Larynx NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic Rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (2.0) View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (2.0) View
Inner Ear/Hearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (2.0) View
Middle Ear/Hearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (2.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Transfusion Prbc's NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Hematologic Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Conduction Abnorm Atrioventricular Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Sinus Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Arrhythmia Super Ventricular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Phlebitis Superficial NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Edema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Thrombosis Embolism NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Ischemia/Cardiac Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Prothrombin Time NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Coagulation Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Partial Thromboplastin Time NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Fever(No Neutropenia) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Weight Loss NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Rigors Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Weight Gain(No Vod) NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Rash Desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Skin Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Nail Changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Pigmentation Changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Photosensitivity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Hand-Foot Skin Reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (2.0) View
Hot Flashes/Flushes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (2.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Diarrhea With Colostomy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Mouth Dryness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Ascites Non-Malignant NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dyspepsia/Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Taste Disturbance NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dysphagia Esophagitis Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Diarrhea Without Colostomy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Stomatitis/Pharyngitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Gi Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Hemorrhage Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Rectal Bleeding/Hematochezia NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Melena/Gi Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hemorrhage Without Grade 3/4 Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Vaginal Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hematuria No Vaginal Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Ggt(Gamma-Glutamyltranspeptidase) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Hepatic Other NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Sgot(Alt) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Sgot(Ast) NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Alkaline Phosphatase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Bilirubin NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Infection Without Neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Lymphatics Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Lymphatics NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Alkalosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Metabolic Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypertyiglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Bicarbonate NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hypomagnesmia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Musculoskeletal Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Muscle Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Extrapyramidal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Depressed Level Of Consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Mood Alteration Anxeity/Agitation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Memory Loss NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Mood Alteration Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Neuropathy Sensor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Pyramidal Tract Dysfunction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Ocular Other NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Tearing NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Vision Blurres NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pain Other NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pain Tumor NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pleuritic Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Neuropathic Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Earache NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Dyspareunia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pelvic Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Bone Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Pain Rectal/Perirectal NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Voice Changes/Stridor/Larynx NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pulmonary Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Ards NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pneumonitis/Pulmonary Infiltrates NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Urinary Frequency/Urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Renal/Gu Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Vaginitis No Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Ureteral Obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Hemoglobinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Bladder Spasms NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Vaginal Dryness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (2.0) View
Libido NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (2.0) View