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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT01373151
Description: None
Frequency Threshold: 5
Time Frame: Up to 48 weeks per participant
Study: NCT01373151
Study Brief: Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
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+MTX BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 2 61 24 61 View
Clazakizumab(25)+MTX BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 5 59 43 59 View
Clazakizumab(100) BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 5 60 43 60 View
Clazakizumab(100)+MTX BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 5 60 51 60 View
Clazakizumab(200) BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 8 59 43 59 View
Clazakizumab(200)+MTX BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks 0 None 5 60 50 60 View
ADA+MTX Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks 0 None 3 59 35 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bursitis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infective tenosynovitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medication error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal wall haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Ejection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders None View
Injection site dermatitis SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Injection site hypersensitivity SYSTEMATIC_ASSESSMENT General disorders None View
Injection site papule SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pruritis SYSTEMATIC_ASSESSMENT General disorders None View
Injection site macule SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiraory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis 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
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferease increased SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View