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: 2025-12-25 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT02015520
Description: As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
Frequency Threshold: 0
Time Frame: Up to 12 weeks for each participant
Study: NCT02015520
Study Brief: Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
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 + Methotrexate (MTX) Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX) 1 None 1 40 14 40 View
Clazakizumab (1 mg) + MTX Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate 0 None 0 21 5 21 View
Clazakizumab (5 mg) + MTX Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate 0 None 0 42 24 42 View
Clazakizumab (25 mg) + MTX Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate 0 None 1 40 28 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SUDDEN DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RENAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LABYRINTHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SKIN CANDIDA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VULVOVAGINAL MYCOTIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LIMB INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FOOT FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
JOINT INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SKIN ABRASION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
HYPERCHOLESTEROLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
BLOOD CHOLESTEROL INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD UREA INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
LOW DENSITY LIPOPROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
NEUTROPHIL COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
WHITE BLOOD CELL COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TENSION HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
EOSINOPHILIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH VESICULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SKIN HYPERPIGMENTATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SKIN ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RHINITIS ALLERGIC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
THROAT IRRITATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HEPATIC FUNCTION ABNORMAL SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
HEPATIC STEATOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
SECONDARY HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
EYE PAIN SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
SEASONAL ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
VULVOVAGINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
AXILLARY PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
DRUG INTOLERANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE BRUISING SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE PRURITUS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE VESICLES SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
VACCINATION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ANAL FISSURE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DENTAL CARIES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
IRRITABLE BOWEL SYNDROME SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TEMPOROMANDIBULAR JOINT SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
TENOSYNOVITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
DYSLIPIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERTRIGLYCERIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INJECTION SITE RASH SYSTEMATIC_ASSESSMENT General disorders MedDRA View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View