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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT00844428
Description:
At every visit, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents, and new or changed concomitant medication regimens. AEs were also documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.).
Frequency Threshold:
0
Time Frame:
Through end of study; Exposure to eculizumab in this study extended for a median of 156 weeks and ranged from 26 weeks to 182 weeks.
Study:
NCT00844428
Study Brief:
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Eculizumab | eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange. | None | None | 13 | 20 | 20 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Amyloidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Gastroenteritis norovirus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Hepatitis E | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Q fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Electrocardiogram T wave inversion | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Catheter removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 15.1 | View |
| Limb operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 15.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Vein disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal clotting factor | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Anaemia folate deficiency | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Microcytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Hypertensive heart disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Dermoid cyst | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 15.1 | View |
| Deafness bilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Motion sickness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 15.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Eye irritation Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Abdominal rigidity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Gingival hyperplasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Gingival ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Malaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Tooth impacted | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Infusion site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Polyp | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.1 | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Ateriovenous fistula site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| BK virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Erythrasma | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Viral pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Arteriovenous fistula site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Foreign body | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Basophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood creatine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood parathyroid hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood pressure abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Electrocardiogram T wave inversion | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Eosinophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Haptoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Monocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Reticulocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| White blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Tendon disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Angiomyolipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Benign breast neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Cerebral haematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Cerebral microangiopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Affective disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 15.1 | View |
| Breast swelling | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Oedema genital | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Lung consolidation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Heat rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Arteriovenous fistula operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 15.1 | View |
| Hip arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 15.1 | View |
| Arterial haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Vein disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |