Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:53 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT03996369
Description: Safety set population included all randomized participants who received at least 1 dose of study intervention.
Frequency Threshold: 0
Time Frame: All-cause mortality, non-serious Treatment-emergent adverse events (TEAEs) and Serious adverse events (SAEs) were collected from first dose of study intervention (Day 1) up to 30 days following discontinuation of the study intervention.
Study: NCT03996369
Study Brief: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
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 Participants were administered one tablet of placebo orally QD for 12 weeks. 0 None 2 116 54 116 View
Etrasimod 2 mg Participants were administered one tablet of etrasimod 2 milligrams (mg) orally once daily (QD) for 12 weeks. 0 None 6 238 112 238 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Hepatobiliary procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Anal eczema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal hypermotility SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Hyperaesthesia teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Lip blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Campylobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Genitourinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infected dermal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations 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 alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Pulmonary function test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
FEV1/FVC ratio decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lung diffusion test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Drug withdrawal headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Blood loss anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Microcytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Underweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eyelid margin crusting SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Meibomian gland dysfunction SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Pigment dispersion syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Metamorphopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Visual snow syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Chorioretinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Exudative retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Cutaneous vasculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Nail bed bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatic cytolysis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Testicular torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Enterocolitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anaemia 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
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Folate deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View