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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT01490450
Description: None
Frequency Threshold: 5
Time Frame: Up to 24 weeks per participant
Study: NCT01490450
Study Brief: Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subcutaneous, every 4 weeks for 24 weeks 0 None 2 41 19 41 View
Clazakizumab (25mg) Subcutaneous, 25 mg, every 4 weeks, for 24 weeks 0 None 2 41 22 41 View
Clazakizumab (100mg) Subcutaneous, 100 mg, every 4 weeks, for 24 weeks 0 None 2 42 20 42 View
Clazakizumab (200mg) Subcutaneous, 200 mg, every 4 weeks, for 24 weeks 0 None 4 41 27 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Adute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder neoplasm 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
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View