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 @ 11:06 PM
Ignite Modification Date: 2025-12-25 @ 8:38 PM
NCT ID: NCT04162769
Description: Safety Population
Frequency Threshold: 0
Time Frame: All-cause mortality, TEAEs and SAEs were collected for Double-blind Treatment period (12-Week) and for OLE Period (52-Week).
Study: NCT04162769
Study Brief: A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
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 Treatment Period: Etrasimod 1 Milligrams (mg) Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. 0 None 0 47 19 47 View
Double-blind Treatment Period: Etrasimod 2 mg Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. 0 None 0 47 31 47 View
OLE Period: Etrasimod 2 mg Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period. 0 None 3 95 53 95 View
Double-blind Treatment Period: Placebo Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study. 0 None 0 46 22 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Extradural abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Extradural abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infection parasitic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Suspected COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Abdominal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ear canal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Coagulation factor increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Full blood count abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Procalcitonin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Axillary mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Essential tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Quadriparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Lower respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Meniere's disease SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eyelid cyst SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View