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 @ 7:08 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT00748657
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) considered to be treatment related for up to 5 years after stopping study treatment
Study: NCT00748657
Study Brief: Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
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 21 days until disease progression or adverse effects prohibit further treatment None None 13 36 36 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
S/N Arrhythmia: Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Ulcer,gi - Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Taste Alteration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Obstruction, Gi - Small Bowel Nos NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Wound NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Pain: Abdominal Pain Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Tumor NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Renal/Genitourinary - Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergy/Immunology - Other NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Hearing (Without Monitoring Program) NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Constitutional Symptoms - Other NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Weight Gain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dermatology/Skin - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hot Flashes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Ulcer,gi - Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Distention NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Taste Alteration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis (Functional/Sympt) - Oral Cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Obstruction, Gi - Small Bowel Nos NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis (Clinical Exam) - Oral Cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrointestinal - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage, Gu - Vagina NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hemorrhage/Pulmonary - Bronchopulmonary Nos NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hemorrhage, Gi - Rectum NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hemorrhage/Pulmonary - Nose NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Inf Unknown Anc: Lung (Pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf Unknown Anc: Sinus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf Unknown Anc: Upper Airway Nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf Unknown Anc: Urinary Tract Nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Edema: Limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Ast NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Gfr NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Metabolic/Laboratory - Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Cholesterol,serum High NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Alkaline Phosphatase NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bilirubin NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bicarbonate, Serum-Low NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Trismus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Joint-Function NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle Weakness - Whole Body/Generalized NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscle Weakness - Extremity-Lower NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neurology - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Mood Alteration - Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Mood Alteration - Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Mood Alteration - Agitation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Memory Impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Flashing Lights/Floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Pain - Other NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Urethra NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Pelvis NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Vagina NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Head/Headache NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Neck NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Extremity-Limb NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Back NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Joint NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Kidney NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Bladder NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Pain Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Stomach NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Oral - Gums NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Skin NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Middle Ear NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Face NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Tumor NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Liver NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Muscle NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pulmonary: Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Nasal/Paranasal Reactions NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Voice Changes NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Vaginal Discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Flu-Like Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Thrombosis/Thrombus/Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Allergic Reaction/Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (3.0) View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Blood/Bone Marrow - Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Ventricular Arrhythmia - Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
S/N Arrhythmia: Sinus Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
S/N Arrhythmia: Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Inr NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Weight Loss NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rigors/Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Death No Ctcae Term - Disease Progression Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nail Changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Injection Site Reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hair Loss/Alopecia (Scalp Or Body) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage, Gi - Oral Cavity NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Ureter NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Ggt NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Alt NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neuropathy-Sensory NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Watery Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Pain: Chest /Thorax Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Chest Wall NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Throat/Pharynx/Larynx NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Oral Cavity NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain: Abdominal Pain Nos NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Cystitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Incontinence, Urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Urinary Frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Libido NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View