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 @ 12:47 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT00167661
Description: None
Frequency Threshold: 0
Time Frame: up to 24 months
Study: NCT00167661
Study Brief: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal 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
Campath 1-H Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant 0 None 2 33 29 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increase Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonas bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Ureteral Stricture SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epigastric Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hydroureter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Eosinophils SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tonsillar cervical, axillary, inguinal hypertrophy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mouth Ulcers SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hives SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphoid hyperplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fine tremor at rest SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fracture L5 SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
High Blood Pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hepatosplenomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ottis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View