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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
NCT ID: NCT00670358
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00670358
Study Brief: Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell 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
Ph 1, DL 1 Phase 1, Dose Level 1 0 None 2 3 3 3 View
Ph1, DL 2 Phase 1, Dose Level 2 0 None 1 3 3 3 View
Ph1, DL 3 Phase 1, Dose Level 3 0 None 2 6 6 6 View
Ph II, DLBCL/Mixed Phase 2, DLBCL/Mixed Dose Level 3 (accrued before 1/1/13) 1 None 26 76 76 76 View
Ph II, Transformed/Composite Phase 2, Transformed/Composite 0 None 15 39 39 39 View
Ph II, Additional DLBCL Phase 2, Additional DLBCL. Accrued after cutoff date 0 None 7 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Skin infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Skin infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Urinary tract infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Pneumonia(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Pneumonia(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Sepsis(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 3 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 3 View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 3 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 3 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 3 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Gastric mucositis (clin exam) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Gastric mucositis (funct/sympt) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Mucositis oral (clin exam) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Small intestinal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 3 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 3 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 3 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 3 View
Bladder infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Colitis, infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Kidney infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Lip infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Otitis media(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Peripheral nerve infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Peripheral nerve infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Pneumonia(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Pneumonia(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Sepsis(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Sinusitis(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Sinusitis(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Skin infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Skin infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Tooth infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Tooth infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Upper respiratory infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Upper respiratory infectn(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Urinary tract infection(gr 0/1/2 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Urinary tract infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Vaginal infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Wound infection(gr 3/4 ANC) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 3 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 3 View
Intraop. inj. - Colon SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 3 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 3 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 3 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 3 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 3 View
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 3 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 3 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 3 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 3 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 3 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 3 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 3 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 3 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 3 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Hand-and-foot syndrome/reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 3 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 3 View