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 @ 3:41 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT00119392
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00119392
Study Brief: Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's 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 (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant) See Detailed Description rituximab: Given IV cyclosporine: Given orally fludarabine phosphate: Given IV mycophenolate mofetil: Given orally yttrium Y 90 ibritumomab tiuxetan: Given IV peripheral blood stem cell transplantation: Undergo transplantation allogeneic hematopoietic stem cell transplantation: Undergo transplantation total-body irradiation: Undergo TBI None None 8 40 36 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenic fever None Blood and lymphatic system disorders None View
Bone pain None General disorders None View
Renal insufficiency None Renal and urinary disorders None View
Hypotension None Vascular disorders None View
Stroke None Nervous system disorders None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View
Sepsis None Infections and infestations None View
Disease progression None Blood and lymphatic system disorders None View
Atrial fibrillation None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia None Metabolism and nutrition disorders None View
Arrhythmia None Cardiac disorders None View
Infection None Infections and infestations None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Dehydration None Metabolism and nutrition disorders None View
Diarrhea None Gastrointestinal disorders None View
Fatigue None General disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Febrile Neutropenia None Blood and lymphatic system disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Pain None General disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Nausea None Gastrointestinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Elevated ALT None Investigations None View
Elevated Creatinine None Investigations None View
Decreased WBC None Investigations None View
Hyponatremia None Metabolism and nutrition disorders None View
Neuropathy None Nervous system disorders None View
Pleural Effusion None Respiratory, thoracic and mediastinal disorders None View
Hypophosphatemia None Gastrointestinal disorders None View
Edema None General disorders None View
Insomnia None Psychiatric disorders None View
Decreased hemoglobin None Investigations None View
Embolism Thrombosis/Thrombus None Vascular disorders None View
Gastritis None Gastrointestinal disorders None View
Obstruction None Gastrointestinal disorders None View
Weakness None General disorders None View
Osteopenia None Musculoskeletal and connective tissue disorders None View