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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) | In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. | None | None | 32 | 772 | 510 | 772 | View |
| CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) | In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30). | None | None | 8 | 162 | 85 | 162 | View |
| CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly) | In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30) | None | None | 4 | 163 | 87 | 163 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| IMPAIRED HEALING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| BILIARY COLIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| CHOLECYSTITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| MASTOIDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PYODERMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TONSILLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VARICELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CHEST INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| CONCUSSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LIGAMENT RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| RADIAL HEAD DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| STERNAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| SPINAL OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| B-CELL LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| MYCOSIS FUNGOIDES | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| PANCREATIC CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| INTERCOSTAL NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| MANIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| PANIC ATTACK | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| FIBRILLARY GLOMERULONEPHRITIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| RENAL CYST HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| URETEROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| ASTHMA EXERCISE INDUCED | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| HYPERVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ACROKERATOSIS PARANEOPLASTICA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DERMATITIS EXFOLIATIVE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPERTENSIVE CRISIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| MYOCARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| VENTRICULAR EXTRASYSTOLES | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| COLITIS ULCERATIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| INTRAOCULAR HAEMATOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| KERATITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| LACRIMATION INCREASED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| VISUAL IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ANAL SKIN TAGS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| ANORECTAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| APHTHOUS ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| COLITIS MICROSCOPIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| IMPAIRED HEALING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE BRUISING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| FUNGAL SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| FURUNCLE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROINTESTINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GASTROINTESTINAL VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GENITAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GENITAL INFECTION FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| GINGIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HELICOBACTER INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OTITIS EXTERNA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OTITIS MEDIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OTITIS MEDIA ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PERICHONDRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PERIODONTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PHARYNGITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PHARYNGITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BILIRUBIN URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD CHOLESTEROL INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BLOOD URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| BODY TEMPERATURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| ELECTROCARDIOGRAM ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| DYSPLASTIC NAEVUS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| FIBROMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| FIBROUS HISTIOCYTOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| MELANOCYTIC NAEVUS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| MONOCLONAL GAMMOPATHY | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| SEBORRHOEIC KERATOSIS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| SKIN PAPILLOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| BURNING SENSATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| CERVICOGENIC VERTIGO | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DYSAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| HYPERAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| NERVE COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| NEURITIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| ORTHOSTATIC INTOLERANCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| ALCOHOL ABUSE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| INITIAL INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| MOOD SWINGS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| NERVOUSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| LEUKOCYTURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| BALANOPOSTHITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| BREAST CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| DYSMENORRHOEA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| SLEEP APNOEA SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| THROAT IRRITATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| ATRIOVENTRICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| BUNDLE BRANCH BLOCK LEFT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| SINUS ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| CONGENITAL NAEVUS | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (19.1) | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| EAR PRURITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| HYPOACUSIS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| SUDDEN HEARING LOSS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| TYMPANIC MEMBRANE PERFORATION | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| THYROID CYST | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (19.1) | View |
| BLEPHARITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| CHALAZION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| CONJUNCTIVAL HYPERAEMIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| CONJUNCTIVITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| ECZEMA EYELIDS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| EYE IRRITATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| EYE SWELLING | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| EYELID OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| EYELIDS PRURITUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| DENTAL CARIES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| EPULIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| FAECES SOFT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| FREQUENT BOWEL MOVEMENTS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTRITIS EROSIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTROINTESTINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GINGIVAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| GINGIVAL EROSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| HYPOAESTHESIA ORAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| INTRA-ABDOMINAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| LARGE INTESTINE POLYP | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| LIP BLISTER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| LIP DRY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| MALLORY-WEISS SYNDROME | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| MOUTH SWELLING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| PARAESTHESIA ORAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| POUCHITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| TONGUE COATED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| TONGUE DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| VASCULITIS GASTROINTESTINAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| APPLICATION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| DRUG THERAPEUTIC INCOMPATIBILITY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| FEELING HOT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJECTION SITE PRURITUS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| INJURY ASSOCIATED WITH DEVICE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PUNCTURE SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| SENSATION OF FOREIGN BODY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| THIRST | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| BILIARY COLIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| HEPATIC STEATOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| SEASONAL ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.1) | View |
| ABDOMINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ANGULAR CHEILITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BACTERIAL RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BACTERIAL VAGINOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BALANITIS CANDIDA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BODY TINEA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| BRONCHITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CANDIDA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CONJUNCTIVITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| CYSTITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ECZEMA IMPETIGINOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| EPIDIDYMITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| EPIGLOTTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| FOLLICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| FUNGAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HERPES VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HERPES ZOSTER INFECTION NEUROLOGICAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| HORDEOLUM | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| IMPETIGO | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LABYRINTHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| LYME DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| MUCOSAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| NAIL BED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| OESOPHAGEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ORAL FUNGAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ORCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| PULPITIS DENTAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SKIN CANDIDA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| STAPHYLOCOCCAL SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| SUBCUTANEOUS ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TINEA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TINEA PEDIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TONSILLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TONSILLITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| TOOTH INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| URETHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VULVOVAGINAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| VULVOVAGINAL MYCOTIC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| ACCIDENT AT WORK | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ANIMAL BITE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ARTHROPOD BITE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ARTHROPOD STING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| BURN ORAL CAVITY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| CERVICAL VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| CRANIOCEREBRAL INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| FOREIGN BODY IN EYE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| HAND FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| JOINT DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| JOINT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LIGAMENT RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| MENISCUS INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| MUSCLE STRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| PLAQUE SHIFT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| PROCEDURAL DIZZINESS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| SKIN ABRASION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| SUBCUTANEOUS HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| SUNBURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| THERMAL BURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| TOOTH FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| ELECTROCARDIOGRAM Q WAVE ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HIGH DENSITY LIPOPROTEIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| HUMAN CHORIONIC GONADOTROPIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| LIVER FUNCTION TEST INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| MONOCYTE COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| FLUID RETENTION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HAEMOSIDEROSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| IRON DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| TYPE 2 DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| VITAMIN D DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| ZINC DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| BURSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| FIBROMYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| JOINT CREPITATION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| JOINT EFFUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| JOINT SWELLING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| METATARSALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MUSCLE TIGHTNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MUSCULOSKELETAL STIFFNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| PATELLOFEMORAL PAIN SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| PSORIATIC ARTHROPATHY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| RHEUMATIC DISORDER | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| SCOLIOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| SPINAL OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| SPINAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| SYNOVIAL CYST | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| TENDONITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| TENOSYNOVITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| CARPAL TUNNEL SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| MENOPAUSAL SYMPTOMS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| MENSTRUATION IRREGULAR | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| METRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| PRURITUS GENITAL | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| NASAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| NASAL MUCOSAL EROSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| OROPHARYNGEAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PHARYNGEAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| ACTINIC KERATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ALOPECIA AREATA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| BLISTER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| BLOOD BLISTER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DERMAL CYST | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DERMATITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DERMATITIS CONTACT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DRUG ERUPTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DYSHIDROTIC ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ECZEMA WEEPING | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ERYTHEMA NODOSUM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| INGROWING NAIL | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| INTERTRIGO | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| MILIARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| MYXOID CYST | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PAIN OF SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PAPULE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PETECHIAE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PHOTODERMATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PHOTOSENSITIVITY REACTION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PRURIGO | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PRURITUS ALLERGIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PRURITUS GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| PUSTULAR PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| RASH PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| ROSACEA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SEBORRHOEA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SEBORRHOEIC DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN ATROPHY | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN EXFOLIATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN FISSURES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN IRRITATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN PLAQUE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SKIN ULCER HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| SOLAR DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| DIASTOLIC HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| FLUSHING | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| LYMPHOEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| PERIPHERAL VENOUS DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| VARICOSE VEIN | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |