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 @ 12:09 AM
Ignite Modification Date: 2025-12-25 @ 10:09 PM
NCT ID: NCT03100058
Description: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Frequency Threshold: 2
Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Study: NCT03100058
Study Brief: A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4) LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4) 0 None 3 38 33 38 View
LIK066 10 mg qd/25 mg qd LIK066 10mg qd (once daily) dosing frequency for 24 weeks 1 None 3 38 24 38 View
LIK066 50 mg qd/25 mg qd LIK066 50mg qd (once daily) dosing frequency for 24 weeks 0 None 1 38 24 38 View
LIK066 150 mg qd/25 mg qd LIK066 150mg qd (once daily) dosing frequency for 24 weeks 0 None 3 77 55 77 View
LIK066 2.5 mg Bid/35 mg qd LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks 1 None 5 38 31 38 View
LIK066 5 mg Bid/35 mg qd LIK066 5mg bid (twice daily) dosing frequency for 24 weeks 0 None 2 39 32 39 View
LIK066 25 mg Bid/35 mg qd LIK066 25mg bid (twice daily) dosing frequency for 24 weeks 0 None 2 38 26 38 View
LIK066 50 mg Bid/35 mg qd LIK066 50mg bid (twice daily) dosing frequency for 24 weeks 0 None 1 76 47 76 View
Placebo/LIK066 25 mg qd (Epoch 4) Matching placebo tablets for 24 weeks 0 None 1 40 32 40 View
Placebo/Placebo Matching placebo tablets 0 None 4 38 32 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Invasive ductal breast carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Leiomyosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Breast enlargement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Polycythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Microvascular coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Porokeratosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (21.0) View
Type IIa hyperlipidaemia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (21.0) View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Eustachian tube dysfunction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Inner ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (21.0) View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (21.0) View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Eye movement disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Myopic chorioretinal degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Bowel movement irregularity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Breath odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Change of bowel habit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Chronic gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dyschezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Eosinophilic oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Faeces hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastrointestinal motility disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastrointestinal sounds abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Splenic artery aneurysm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Hunger SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Biliary dyskinesia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (21.0) View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (21.0) View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Bacterial vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Balanitis candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Cystitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Genital candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Genital herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Genital infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Otitis externa fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Sinobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Vestibular neuronitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Anastomotic ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Muscle rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Amylase decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Apolipoprotein A-I decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood albumin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Creatinine urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Electrocardiogram change SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Glomerular filtration rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Haematocrit increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Haemoglobin urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
High density lipoprotein decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Lipase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Liver scan abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Serum ferritin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Urine albumin/creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Urine leukocyte esterase SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Appetite disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Ketosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (21.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Dupuytren's contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Exostosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Extremity contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Tendon pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Adenoma benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Benign neoplasm of conjunctiva SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Neuroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Hyposmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Unintended pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (21.0) View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA (21.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Binge drinking SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Grief reaction SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Organic brain syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Lower urinary tract symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Microalbuminuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (21.0) View
Atrophic vulvovaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Breast haematoma SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Epididymal cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Menopausal symptoms SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Menstrual disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Vulval disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Lichen sclerosus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Pustular psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (21.0) View