Adverse Events Module

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 @ 12:29 AM
Ignite Modification Date: 2025-12-25 @ 10:35 PM
NCT ID: NCT04178967
Description: All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Frequency Threshold: 0
Time Frame: Baseline up to Week 52
Study: NCT04178967
Study Brief: Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in 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
Induction - Placebo Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. 1 None 4 149 97 149 View
Induction - Lebrikizumab 250mg Q2W Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14. 0 None 2 295 157 295 View
Maintenance Blinded - Lebrikizumab Responder/ Placebo Maintenance Period (Week 16 to Week 52): One 250 mg SC injection of Placebo Q2W. 0 None 1 30 15 30 View
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. 0 None 0 59 32 59 View
Maintenance Blinded - Placebo Responder/ Placebo Maintenance Blinded - Placebo Responder/ Placebo 0 None 0 5 3 5 View
Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W Maintenance Period (Week 16 to Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. 0 None 2 9 4 9 View
Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W 0 None 0 11 8 11 View
Escape Arm Week 16 - Maintenance Open Label (OL) -Placebo Non-Responder/Lebrikizumab Q2W Maintenance Escape Period (Week 16 to Week 52): One 250 mg Lebrikizumab SC injection Q2W. 0 None 1 108 68 108 View
Escape Arm Week 24 to 48 - Maintenance Lebrikizumab Maintenance Escape Period (Week 24 to Week 48): One 250 mg Lebrikizumab SC injection Q2W. 0 None 0 11 5 11 View
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q2W Maintenance Period (Week 16 to Week 52): One 250 mg Lebrikizumab SC injection Q2W. 0 None 2 59 36 59 View
Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W Maintenance Escape Period (Week 16to Week 52): One 250 mg Lebrikizumab SC injection Q2W. 1 None 5 125 77 125 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Rhegmatogenous retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Paternal exposure during pregnancy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Cerebellar syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cerebellar syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Paraesthesia ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Atopic keratoconjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Dark circles under eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Epiretinal membrane SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Episcleritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eyelid cyst SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eyelid erosion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Keratoconus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal pain 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
Angular cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dental caries 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
Epiploic appendagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urine ketone body present SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Penis disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Polycystic ovaries SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pityriasis rosea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Osteitis 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
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Fibroadenoma of breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Ovarian germ cell teratoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Narcolepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Middle insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Sleep disorder due to general medical condition, insomnia type SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Bladder disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Bladder irritation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Bartholin's cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Breast hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Breast ulceration SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Allergic sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal septum deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Throat tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Alopecia areata SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis psoriasiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Diffuse alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dyshidrotic eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hair disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Prurigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Seborrhoea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin lesion inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Urticaria papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Aortic arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Auricular pseudocyst SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Oral mucosal eruption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Cyst rupture SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Injection site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Vaccination site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Allergy to animal SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Asymptomatic bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Demodicidosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Dermatitis infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Dermatophytosis of nail SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Eczema herpeticum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Eczema impetiginous SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Eczema infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Genital herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Ophthalmic herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Oral infection 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
Perineal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Superinfection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea barbae SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea capitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea cruris SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tinea versicolour SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tonsillitis bacterial 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
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Accident at work SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Bone contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Injury corneal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Neck injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Overdose 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
Procedural headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Stress fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Tibia fracture 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 dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood alkaline phosphatase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood testosterone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Eosinophil count increased 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
Lymphocyte percentage decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Mean cell haemoglobin concentration decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Mean cell volume increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Coccydynia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Flank 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
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Hypochromic 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