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: 2025-12-24 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT01856192
Description: Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Frequency Threshold: 5
Time Frame: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 10 years.
Study: NCT01856192
Study Brief: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large 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
Arm A (R2CHOP) Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. 36 None 128 166 164 166 View
Arm B (RCHOP) Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. 43 None 117 171 164 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Toxic epidermal necrolysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Musculoskeletal and connective tissue disorder - Other, spe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Trigeminal nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Leukemia secondary to oncology chemotherapy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 4.0 View
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 4.0 View
Neoplasms benign, malignant and unspecified (incl cysts and SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 4.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View