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 @ 2:25 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
NCT ID:
NCT00270634
Description:
AEs were assessed at each clinic visit throughout the study.
Frequency Threshold:
5
Time Frame:
6 month treatment
Study:
NCT00270634
Study Brief:
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High Dose Voclosporin | High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID | None | None | 40 | 87 | 84 | 87 | View |
| Mid Dose Voclosporin | Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID | None | None | 35 | 77 | 76 | 77 | View |
| Low Dose Voclosporin | Low dose voclosporin: Initial dose of 0.4 mg/kg po BID | None | None | 36 | 84 | 83 | 84 | View |
| Tacrolimus | Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID | None | None | 37 | 86 | 85 | 86 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Acute Coronary Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Peridontal Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Retroperitoneal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Kidney Transplant Rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| Transplant Rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| Abcess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Clostridial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Cytomegalovirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Enterococcal Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Gastritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Hepatitis A | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Localized Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Complications of Transplanted Kidney | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Hip Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Perinephric Collection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Post Procedural Haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Renal Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Renal Lymphocele | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Therapeutic Agent Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Urinary Anastomotic Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Post Procedural Urine Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Electrocardiogram ST Segment Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| International Normalised Ratio Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Liver Function Test Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Papillary Tumour of Renal Pelvis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Anoxic Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Neurological Symptom | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Reversible Posterior Leukoencephalopathy Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Acute Psychotic | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Anastomotic Stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Complications of Transplanted Kidney | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Glomerulonephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal Artery Stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal Impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal Tubular Necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Urethral Obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Benign Prostatic Hyperplagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 8.1 | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Respiratory Distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Cyst Drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| Lymphocele Marsupialisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| Nephrectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| Aortic Aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Hypertensive Crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Orthostatic Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Peripheral Ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Steal Syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Subclavian Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| In-Stent Coronary Artery Restenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Unstable Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal Strangulated Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Colonic Pseudo-Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Diarhhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Inguinal Hernia, Obstructive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Large Intestine Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Oesophageal Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Polyomavirus-Associated Nephropathy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Post Operative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Oesophageal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LEUKOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 8.1 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 8.1 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 8.1 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| KIDNEY TRANSPLANT REJECTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| INCISION SITE COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| PERINEPHRIC COLLECTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| WOUND DEHISCENCE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| LIVER FUNCTION TEST ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| URINE OUTPUT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPERPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| METABOLIC ACIDOSIS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| PHARYNGOLARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| HAIR GROWTH ABNORMAL | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| HYPERTRICHOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| INCISIONAL DRAINAGE | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| WOUND DRAINAGE | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |