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: 2025-12-24 @ 2:04 PM
Ignite Modification Date: 2025-12-25 @ 12:48 PM
NCT ID: NCT00816595
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00816595
Study Brief: Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV None None 11 33 32 33 View
Arm B: Pentostatin, Cyclophosphamide, and Rituximab Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV None None 5 33 30 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Bladder hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Protein urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Gallbladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Protein urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View