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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jardiance | Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jardiance | Drug | Empagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | Number of patients with adverse drug reactions. | From first drug administration until 7 days after last drug administration, up to 247 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period. | At start of treatment and at last observation on treatment, up to 246 weeks. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period |
Not provided
Inclusion criteria:
Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment
Exclusion criteria:
None
Not provided
Not provided
Not provided
3,000 Japanese patients with the assessment of 3-year completed administration
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31769309 | Derived | Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment.
A non-interventional study to investigate the safety and efficacy of longterm daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | JARDIANCE® User 10 Milligram (mg) or 25 mg | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set: All patients who had received treatment of JARDIANCE® tablet at least one time except those who were found to have no observation after enrollment, invalid registration, or invalid contract with the site.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | JARDIANCE® User 10 Milligram (mg) or 25 mg | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Set. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Drug Reactions (ADRs) | Number of patients with adverse drug reactions. | Safety Set: All patients who had received treatment of JARDIANCE® tablet at least one time except those who were found to have no observation after enrollment, invalid registration, or invalid contract with the site. | Posted | Count of Participants | Participants | From first drug administration until 7 days after last drug administration, up to 247 weeks. |
|
From first drug administration until 7 days after last drug administration, up to 247 weeks.
Safety Set: All patients who had received treatment of JARDIANCE Tablet at least one time except those who were found to have no observation after enrolment, invalid registration, or invalid contract with the site.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JARDIANCE® User 10 Milligram (mg) or 25 mg | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
Since this surveillance was an observational, non interventional study, it lacked the methodological rigour of a randomised control trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0217 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2015 | Nov 19, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2020 | Nov 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period. |
| At start of treatment and at last observation on treatment, up to 246 weeks. |
| Adverse Event |
|
| Other personal reasons |
|
| Lost to Follow-up |
|
| Not continuously investigated |
|
| Patient started jardiance treatment out of registration period |
|
| Multiple registration |
|
| No patient visit after entry |
|
| No treatment with Jardiance |
|
| Patient received Jardiance before registration |
|
| No CRF collected |
|
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Safety Set | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period. | Efficacy set: All patients in the safety set, except patients who had no available efficacy data and/or do not suffer from type 2 diabetes mellitus. | Posted | Mean | Standard Deviation | Percentage change | At start of treatment and at last observation on treatment, up to 246 weeks. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period | Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period. | All patients included in the efficacy set and with available data for this endpoint. | Posted | Mean | Standard Deviation | Milligram/deciliter (mg/dL) | At start of treatment and at last observation on treatment, up to 246 weeks. |
|
|
|
| 42 |
| 7,947 |
| 381 |
| 7,947 |
| 0 |
| 7,947 |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Adams-Stokes syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bundle branch block bilateral | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Silent myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cataract diabetic | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Normal tension glaucoma | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vascular stent stenosis | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Biliary obstruction | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Immune system disorders | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Anaphylactic shock | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Diabetic gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Endometritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Lymph gland infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Acute hepatitis B | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Emphysematous pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Complicated appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Adrenal gland injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Metabolism and nutrition disorders | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Hyperglycaemia | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Diabetes mellitus | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Hypoglycaemia | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Dehydration | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Diabetic ketosis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Ketoacidosis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Marasmus | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Dyslipidaemia | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Osteoarthritis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Arthralgia | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Fracture malunion | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Muscle spasms | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Rhabdomyolysis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Spinal stenosis | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Pharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Rectal cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Ureteral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Ovarian cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Soft tissue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebellar atrophy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Moyamoya disease | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Neuralgic amyotrophy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Generalised onset non-motor seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiovascular somatic symptom disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Enterostomy | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Infarction | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Subclavian vein occlusion | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |