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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT00066469
Description: One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
Frequency Threshold: 0
Time Frame: None
Study: NCT00066469
Study Brief: Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cyclophosphamide, Prednisone, Rituximab Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease. None None 2 54 38 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinus bradycardia None Cardiac disorders None View
Death NOS None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Blood and lymphatic system disorders - Other, specify None Blood and lymphatic system disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Sinus tachycardia None Cardiac disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders None View
Lower gastrointestinal hemorrhage None Gastrointestinal disorders None View
Mucositis oral None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Chills None General disorders None View
Death NOS None General disorders None View
Fever None General disorders None View
Hepatic hemorrhage None Hepatobiliary disorders None View
Hepatic necrosis None Hepatobiliary disorders None View
Bronchial infection None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Enterocolitis infectious None Infections and infestations None View
Infections and infestations - Other, specify None Infections and infestations None View
Kidney infection None Infections and infestations None View
Lung infection None Infections and infestations None View
Peritoneal infection None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Skin infection None Infections and infestations None View
Small intestine infection None Infections and infestations None View
Postoperative hemorrhage None Injury, poisoning and procedural complications None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Blood bilirubin increased None Investigations None View
Cholesterol high None Investigations None View
Creatinine increased None Investigations None View
GGT increased None Investigations None View
Investigations - Other, specify None Investigations None View
Lipase increased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
Serum amylase increased None Investigations None View
White blood cell decreased None Investigations None View
Acidosis None Metabolism and nutrition disorders None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypertriglyceridemia None Metabolism and nutrition disorders None View
Hyperuricemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View
Dizziness None Nervous system disorders None View
Nervous system disorders - Other, specify None Nervous system disorders None View
Seizure None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Renal hemorrhage None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View