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 @ 9:26 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
NCT ID: NCT00801632
Description: None
Frequency Threshold: 5
Time Frame: Transplantation until study completion or participant termination (up to five years)
Study: NCT00801632
Study Brief: Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MEDI-507 Recipients received a conditioning treatment that started with rituximab (375 mg/m\^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant. None None 5 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Engraftment syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Catheter related complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Drug toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View