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 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT02628405
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 years
Study: NCT02628405
Study Brief: R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory 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
Treatment (R2-ICE) Rituximab: Given IV 12 None 16 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 4 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 4 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 4 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 4 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 4 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 4 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 4 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4 View