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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazenta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazenta | Drug | 1 tablet of 5 mg Trazenta tablets once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug Related Adverse Events | Percentage of participants with drug related adverse events. | From first drug administration until last drug administration, up to approximately 156 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) | The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c). | Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. |
Not provided
Inclusion criteria:
Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.
Exclusion criteria:
None
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3000 patients with type 2 Diabetes Mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33269625 | Derived | Ito T, Naito Y, Shimmoto N, Ochiai K, Hayashi N, Okamura T. Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance. Expert Opin Drug Saf. 2021 Mar;20(3):363-372. doi: 10.1080/14740338.2021.1859477. Epub 2020 Dec 27. |
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This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g., demographics, baseline characteristics, concomitant drugs in use) were defined for participant enrolment. Participants were enrolled from July 2013 to September 2015.
An observational, non-randomised, non-interventional study (NIS) in participants diagnosed with type 2 diabetes mellitus (T2DM) who were treated as add-on therapy were included in the surveillance based on newly collected data under routine medical practice.
Acronym used:
Case report form (CRF)
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| ID | Title | Description |
|---|---|---|
| FG000 | Trazenta® | Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trazenta® | Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Drug Related Adverse Events | Percentage of participants with drug related adverse events. | Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included. | Posted | Number | Percentage (%) of participants | From first drug administration until last drug administration, up to approximately 156 weeks. |
|
For Serious adverse events (AEs) and other AEs: From first drug administration until last drug administration, up to approximately 156 weeks. For All-cause mortality: From first drug administration until end of trial, up to approximately 238 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trazenta® | Participants suffering from T2DM were orally treated with Trazenta® 5 milligram (mg) tablets once daily, for 156 weeks or until discontinuation of administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 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 | Jun 7, 2013 | Sep 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2018 | Sep 5, 2019 | 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
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| Lack of Efficacy |
|
| Improvement |
|
| Adverse Event |
|
| No patient visit after entry |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) | The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c). | Efficacy set: This patient set included all patients with Trazenta® Tablets in the safety set who had a baseline and at least one available on-treatment HbA1c value and had type 2 diabetes mellitus. | Posted | Mean | Standard Deviation | Percentage (%) | Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. |
|
|
|
| 74 |
| 3,372 |
| 304 |
| 3,372 |
| 184 |
| 3,372 |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Adrenal gland cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Hepatic cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Pancreatic carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Basilar artery occlusion | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiac sarcoidosis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiomyopathy alcoholic | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Eosinophilic pneumonia chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Superior mesenteric artery syndrome | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rapidly progressive osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| End stage renal disease | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Carbohydrate antigen 19-9 increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |