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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT00243659
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00243659
Study Brief: Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bolus Injection Approximately 50 IU/kg Refacto AF for 6 consecutive days None None 4 None 19 None View
Continuous Infusion Approximately 50 IU/Kg Refacto AF then continuously None None 1 None 7 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Accidental injury NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Factor VIII inhibition NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cough increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Accidental injury NON_SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-specified drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypovolemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pallor NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocythemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bilirubinemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Peripheral edema NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Plantar fascitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vesiculobullous rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abnormal vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ear disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney calculus NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Scrotal edema NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Location reaction to procedure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Jaundice NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View