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 |
|---|---|---|---|---|---|---|---|---|
| Sirolimus (SRL) | Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn. On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks. Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited. | None | None | 39 | 79 | 79 | 79 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Parotitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lymphocele | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Asphyxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Haemolytic uraemic syndrome | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal mass | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gingival hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Epigastric discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oral disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Oral discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Faecal incontinence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anorectal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood phosphorus decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood albumin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood calcium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea versicolour | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vaginal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea cruris | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| BK virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gingival infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyperamylasaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Generalised oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pitting oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mass | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sense of oppression | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Xerosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hirsutism | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Neurodermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Toxic skin eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Swelling face | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Postoperative wound complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Coccydynia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Azotaemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Albuminuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal tubular necrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Amenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Genital haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Visual disturbance | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Xerophthalmia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Conjunctival oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Lymphocele | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Cushingoid | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |