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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT02962960
Description: An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT02962960
Study Brief: A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anifrolumab - Lower Dose 1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50 0 None 4 14 12 14 View
Anifrolumab - Higher Dose 2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50 0 None 2 13 11 13 View
Placebo Comparator Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50 0 None 0 9 7 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Systemic Lupus Erythematosus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
Lupus Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
Spinal Compression Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Conjunctivitis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 21.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 21.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 21.1 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.1 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 21.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
Pericardial Cyst SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Nasal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Nasal Septum Perforation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21.1 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Paraesthesia Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21.1 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
Spinal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21.1 View
Anembryonic Gestation SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA version 21.1 View
Endometrial Hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 21.1 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Face Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.1 View
Mycobacterium Tuberculosis Complex Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.1 View
Subcutaneous Haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21.1 View