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: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT00410605
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00410605
Study Brief: Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma
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, Dexamethasone, and Lenalidomide Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV lenalidomide: Given orally dexamethasone: Given orally None None 22 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation None Cardiac disorders None View
Left Ventricular Systolic Dysfunction None Cardiac disorders None View
Hypothyroidism None Endocrine disorders None View
Colonic Perforation None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Fever None General disorders None View
Infections and Infestations, Other None Infections and infestations None View
Lung Infection None Infections and infestations None View
Mucosal Infection None Infections and infestations None View
Upper Respiratory Infection None Infections and infestations None View
Blood Bilirubin Increased None Investigations None View
Cardiac Troponin T Increased None Investigations None View
Lymphocyte Count Decreased None Investigations None View
Neutrophil Count Decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Hypercalcemia None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperuricemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Chest Wall Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Treatment Related Secondary Malignancy - Chronic Lymphocytic Leukemia None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dysgeusia None Nervous system disorders None View
Peripheral Sensory Neuropathy None Nervous system disorders None View
Confusion None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Acute Kidney Injury None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Hypertension None Vascular disorders None View
Thromboembolic Event None Vascular disorders None View
Atrial flutter None Cardiac disorders None View
Heart failure None Cardiac disorders None View
Retinal Detachment None Eye disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Duodenal Hemorrhage None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Mucositis Oral None Gastrointestinal disorders None View
Small Intestinal Perforation None Gastrointestinal disorders None View
Death NOS None General disorders None View
Edema Limbs None General disorders None View
White Blood Cell Decreased None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain None Gastrointestinal disorders None View
Alanine aminotransferase increased None Investigations None View
Anxiety None Psychiatric disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased None Investigations None View
Back pain None Musculoskeletal and connective tissue disorders None View
Blood bilirubin increased None Investigations None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Blurred vision None Eye disorders None View
Bruising None Injury, poisoning and procedural complications None View
Chills None General disorders None View
Confusion None Psychiatric disorders None View
Constipation None Gastrointestinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Creatinine increased None Investigations None View
Depression None Psychiatric disorders None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Dry mouth None Gastrointestinal disorders None View
Dysgeusia None Nervous system disorders None View
Dyspepsia None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Edema limbs None General disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Flatulence None Gastrointestinal disorders None View
Flushing None Vascular disorders None View
generalized muscle weakness None Musculoskeletal and connective tissue disorders None View
Gum infection None Infections and infestations None View
Headache None Nervous system disorders None View
Hemorrhoids None Gastrointestinal disorders None View
hyperglycemia None Metabolism and nutrition disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Insomnia None Psychiatric disorders None View
Lymphocyte count decreased None Investigations None View
Mucosal infection None Infections and infestations None View
Mucositis oral None Gastrointestinal disorders None View
Muscle weakness lower limb None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Personality change None Psychiatric disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased None Investigations None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Sinus disorder None Respiratory, thoracic and mediastinal disorders None View
Sinusitis None Infections and infestations None View
Skin infection None Infections and infestations None View
Tooth infection None Infections and infestations None View
Tremor None Nervous system disorders None View
Upper respiratory infection None Infections and infestations None View
Urinary frequency None Renal and urinary disorders None View
Urinary Tract Infection None Infections and infestations None View
Voice alteration None Respiratory, thoracic and mediastinal disorders None View
Vomiting None Gastrointestinal disorders None View
Weight loss None Investigations None View
White blood cell decreased None Investigations None View
Alkaline Phosphatase Increased None Investigations None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Anemia None Blood and lymphatic system disorders None View
Anorexia None Metabolism and nutrition disorders None View