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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT01466166
Description: None
Frequency Threshold: 5
Time Frame: From first dose of study drug to the end of the 12-week follow-up period (63 weeks).
Study: NCT01466166
Study Brief: Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic 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
Pegloticase Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician. 3 None 31 188 130 188 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Gastrointestinal arteriovenous malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 17.1 View
Large intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View