Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
NCT ID:
NCT05335356
Description:
None
Frequency Threshold:
1
Time Frame:
Treatment Emergent Adverse Events (TEAEs) through the Study (Week 52)
Study:
NCT05335356
Study Brief:
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bmab1200 | Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40 | 0 | None | 6 | 191 | 111 | 191 | View |
| Stelara | Stelara 45 mg Stelara 90 mg Stelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara | 0 | None | 0 | 101 | 48 | 101 | View |
| Stelara-Bmab1200 | Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg Subject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg | 0 | None | 1 | 92 | 51 | 92 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Squamous cell carcinoma of the tongue | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Endometrial adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Uterovaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Tonsillitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Asymptomatic bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Giardiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Peritonsillar abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Sinusitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Tongue fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urethritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urinary tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Lipids increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood glucose abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Glucose urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Haemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| High density lipoprotein decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Monocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| White blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Acquired mixed hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Latent autoimmune diabetes in adults | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Metabolic syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Erythropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Secondary thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Leukocyturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Ketonuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Hyperoxaluria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Sensitive skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Psoriatic arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Joint contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Fractured coccyx | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Post-traumatic pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Bundle branch block right | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cardiac discomfort | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Left atrial enlargement | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Illness anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Genital haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Menstruation irregular | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Uterovaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| Essential hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Endometrial adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Haemangioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Squamous cell carcinoma of the tongue | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.1 | View |
| Tympanic membrane perforation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.1 | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |