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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT02453256
Description: The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.
Frequency Threshold: 5
Time Frame: Up to Week 96
Study: NCT02453256
Study Brief: A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Double-Blind Placebo Participants received double-blind matching placebo from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96. 3 None 18 106 59 106 View
Double-Blind Tocilizumab Participants received double-blind tocilizumab from Baseline to Week 48. Participants may then receive open-label tocilizumab from Weeks 48 to 96. 1 None 13 104 60 104 View
Placebo, Then Tocilizumab Open Label Participants who received placebo during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. 1 None 7 89 46 89 View
Tocilizumab, Then Tocilizumab Open Label Participants who received tocilizumab during the double blind period from Baseline to Week 48, received tocilizumab from Week 48 to Week 96. 1 None 10 92 28 92 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LIMB TRAUMATIC AMPUTATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
RADIUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
SPINAL CORD INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
DIABETIC KETOACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
JOINT STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
SCLERODERMA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
ANAEMIA MEGALOBLASTIC SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
LYMPHADENOPATHY MEDIASTINAL SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
CARDIAC FAILURE CHRONIC SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
CARDIAC TAMPONADE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
CONGESTIVE CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
MICROVASCULAR CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
MYOCARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
RETINAL VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
GASTRITIS EROSIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
ILEUS PARALYTIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
RECTAL PROLAPSE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
INFECTED SKIN ULCER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
INFECTIVE TENOSYNOVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
OTITIS MEDIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
PELVIC INFLAMMATORY DISEASE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
PYELONEPHRITIS CHRONIC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
SOFT TISSUE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
FEMORAL NECK FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
TENDONITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
TENOSYNOVITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
TRIGGER FINGER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
B-CELL LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
BENIGN BONE NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
LUNG ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
BRAIN INJURY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
ADJUSTMENT DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
SCLERODERMA RENAL CRISIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
PNEUMONIA ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
DIGITAL PITTING SCAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
ECCHYMOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
INTERSTITIAL LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View