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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00906204
Description: Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
Frequency Threshold: 5
Time Frame: One year.
Study: NCT00906204
Study Brief: Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney 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
Single-dose Thymoglobulin Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation None None 23 44 44 44 View
Divided-dose Thymoglobulin Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. None None 21 51 49 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
serum sickness SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hyperkalemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
abdominal fullness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
death SYSTEMATIC_ASSESSMENT General disorders None View
orthostatic hypotension SYSTEMATIC_ASSESSMENT General disorders None View
cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hepatitis C exposure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
BK virus SYSTEMATIC_ASSESSMENT Infections and infestations None View
C. difficile SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Histoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Gasteroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
rATG reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chronic lymphoid leukemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Delayed graft function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Interstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Native nephrectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrostomy tube placement SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Perinephric hematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rejection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal vein thrombosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wound hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Osteopenia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Tacrolimus elevation/toxicity SYSTEMATIC_ASSESSMENT General disorders None View
Elevated liver enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
BK virus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pancytopenia SYSTEMATIC_ASSESSMENT Immune system disorders None View
C. difficile SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Possible rATG reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated serum creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rejection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hernia SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Wound complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View