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 |
|---|---|---|---|---|---|---|---|---|
| Raxone | Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals) | 1 | None | 27 | 198 | 148 | 198 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Disease Reoccurance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Hypogammaglobulinaemia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Diverticulitis intestinal perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Trichomoniasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Vulvovaginitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Urobilinogen urine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Alcohol abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Psychotic behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Drug reaction with eosinophilia and systemic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRa 24.0 | View |
| Miscarriage of partner | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRa 24.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRa 24.0 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa | View |
| Total | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Total | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa 24.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa 24.0 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa 24.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa 24.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRa 24.0 | View |
| Hereditary optic atrophy | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRa 24.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRa 24.0 | View |
| Excessive cerumen production | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRa 24.0 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRa 24.0 | View |
| Motion sickness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRa 24.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRa 24.0 | View |
| Thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Eye haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Eyelid pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Pupils unequal | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Abdominal migraine | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Dental necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Eosinophilic oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Infrequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Malpositioned teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Salivary hypersecretion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Tooth disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Tooth impacted | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Polyp | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRa 24.0 | View |
| Hepatosplenomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Bacterial abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Bronchitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Enterobiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Hepatitis C | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRa 24.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Pulpitis dental | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRa 24.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Foreign body in eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Heat stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Product administration error | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Bacterial test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood creatine phosphokinase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood triglycerides increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood urea decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Eosinophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Gastric pH decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Haematocrit decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Mean cell volume increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Mean cell volume increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Monocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Monocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Protein urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Red blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Urinary sediment present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Urine ketone body present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| White blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Periarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Periostitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa 24.0 | View |
| Anogenital warts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Hyperaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Ophthalmic migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Adjustment disorder with depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Anger | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Depressive symptom | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Hallucination, visual | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Polydipsia psychogenic | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Suicidal behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRa 24.0 | View |
| Urine abnormality | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRa 24.0 | View |
| Cervical dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRa 24.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRa 24.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRa 24.0 | View |
| Testicular pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Allergic bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Upper respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRa 24.0 | View |
| Orthosis user | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRa 24.0 | View |
| Pregnancy of partner | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Ingrown hair | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Scab | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRa 24.0 | View |
| Total | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa 24.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa 24.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa 24.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa 24.0 | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRa 24.0 | View |