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 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT00111657
Description: None
Frequency Threshold: 1
Time Frame: Day 134
Study: NCT00111657
Study Brief: Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
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 Arm - Pegloticase None None None 4 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal bleeding. NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Physician defined. View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Physician defined. View
Bowel perforation. NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders Physician defined. View
Urinary hesitancy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders Physician defined. View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Infected tophus NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Rectal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Skin abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Thrush NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Physician defined. View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Physician defined. View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Physician defined. View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Charcot joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Draining tophus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Gout flare NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Joint stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Pain in limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Physician defined. View
Parasthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Physician defined. View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Physician defined. View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders Physician defined. View
Conjunctival injection NON_SYSTEMATIC_ASSESSMENT Eye disorders Physician defined. View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Decreased libido NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Excessive sleepiness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Labile affect NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Physician defined. View
Chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Chest tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Obstructive sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Hypoxemia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Physician defined. View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Contact dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Foot ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Leg ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Swellng of toes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Nevi NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Seborrheic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Physician defined. View
Edema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Physician defined. View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Physician defined. View
Syncope NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Physician defined. View
Chronic gouty arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Physician defined. View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Physician defined. View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Physician defined. View
Abdominal cramping NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Physician defined. View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders Physician defined. View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders Physician defined. View