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 @ 4:54 PM
Ignite Modification Date: 2025-12-25 @ 2:37 PM
NCT ID: NCT01545050
Description: None
Frequency Threshold: 2
Time Frame: Up to 12 weeks per participant
Study: NCT01545050
Study Brief: Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
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 Intravenous (IV), Day One Only Subcutaneous (SC), Every 4 weeks for 8 weeks 0 None 2 18 1 18 View
Clazakizumab (150 IV/100 SC) IV, 150 mg, Day One Only SC, 100 mg, Week 8 Only, One Day 0 None 2 9 2 9 View
Clazakizumab (400 SC/200 SC) SC, 400 mg, Day One and Week 4 SC, 200 mg, Week 8 only, One Day 0 None 6 18 8 18 View
Clazakizumab (600 IV/200 SC) IV, 600 mg, Day One Only SC, 200 mg, Week 8 Only, One Day 0 None 4 18 2 18 View
Clazakizumab (300 IV/100 SC) IV, 300 mg, Day One Only SC, 100 mg, Week 8 Only, One Day 1 None 2 9 3 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cronh's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorectal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anal fistula infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail dystrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin depigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations None View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations None View