Viewing Study NCT02848833

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:53 AM
Ignite Modification Date: 2026-03-03 @ 8:18 PM
Study NCT ID: NCT02848833
Status: COMPLETED
Last Update Posted: 2021-05-11
First Post: 2016-06-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.', 'eventGroups': [{'id': 'EG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.', 'otherNumAtRisk': 3231, 'deathsNumAtRisk': 3231, 'otherNumAffected': 0, 'seriousNumAtRisk': 3231, 'deathsNumAffected': 0, 'seriousNumAffected': 55}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pathologic myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular stent stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular stent thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Splenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cervix inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign neoplasm of ampulla of Vater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3231, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.93', 'groupId': 'OG000', 'lowerLimit': '12.75', 'upperLimit': '15.17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events Relating to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.14', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '5.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Unexpected Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000', 'lowerLimit': '10.46', 'upperLimit': '12.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.93'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.\n\nThe following are considered as AESIs:\n\n* Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection\n* Increased urination\n* Urinary tract infection (UTI)\n* Volume depletion\n* Diabetic Ketoacidosis (DKA)\n* Decreased renal function:\n* Hepatic injury\n* Lower limb amputation', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '2.67', 'upperLimit': '3.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2567', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '1.39', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'Difference before administration versus after administration was analyzed using a paired t-test.', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.', 'unitOfMeasure': 'Percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2567', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'title': 'lower than 7%', 'measurements': [{'value': '1132', 'groupId': 'OG000'}]}, {'title': 'greater than or equal to 7%', 'measurements': [{'value': '1435', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2567', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'title': 'greater than or equal to 0.5%', 'measurements': [{'value': '1315', 'groupId': 'OG000'}]}, {'title': 'lower than 0.5%', 'measurements': [{'value': '1252', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.59', 'spread': '59.84', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'Difference before administration versus after administration was analyzed using a paired t-test.', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in fasting plasma glucose (FPG) at last visit.', 'unitOfMeasure': 'milligram per deciliter (mg/dl)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2097', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '3.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference before administration versus after administration was analyzed using a paired t-test.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in body weight at last visit.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2355', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.95', 'spread': '15.44', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'Difference before administration versus after administration was analyzed using a paired t-test.', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in systolic blood pressure (SBP) at last visit.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2354', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.80', 'spread': '10.82', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'Difference before administration versus after administration was analyzed using a paired t-test.', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in diastolic blood pressure (DBP) at last visit.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Final Effectiveness Assessment Category at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2567', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '1749', 'groupId': 'OG000'}]}, {'title': 'Unchanged', 'measurements': [{'value': '546', 'groupId': 'OG000'}]}, {'title': 'Aggravated', 'measurements': [{'value': '195', 'groupId': 'OG000'}]}, {'title': 'Unassessable', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3368'}]}, {'type': 'COMPLETED', 'comment': 'All Participants whose case report forms (CRFs) were retrieved during the re-examination period and who did not violate the inclusion/exclusion criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3231'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}], 'dropWithdraws': [{'type': 'subject who are duplicated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'have not taken the study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'follow-up failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}]}]}], 'recruitmentDetails': 'This was and observational prospective, non-interventional, open-label, multi-centre study to monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10 milligram (mg), 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'JARDIANCE®', 'description': 'JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.66', 'spread': '11.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3231', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1380', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1851', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-23', 'size': 588416, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-19T06:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2016-06-27', 'resultsFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-15', 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Any Adverse Events', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.'}, {'measure': 'Percentage of Participants With Adverse Events Relating to Study Drug', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.'}, {'measure': 'Percentage of Participants With Unexpected Adverse Events', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.'}, {'measure': 'Percentage of Participants With Adverse Events of Special Interest', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.\n\nThe following are considered as AESIs:\n\n* Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection\n* Increased urination\n* Urinary tract infection (UTI)\n* Volume depletion\n* Diabetic Ketoacidosis (DKA)\n* Decreased renal function:\n* Hepatic injury\n* Lower limb amputation'}, {'measure': 'Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug', 'timeFrame': 'From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.', 'description': 'Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.'}, {'measure': 'Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit', 'timeFrame': 'At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.'}, {'measure': 'Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in fasting plasma glucose (FPG) at last visit.'}, {'measure': 'Change From Baseline in Body Weight at Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in body weight at last visit.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in systolic blood pressure (SBP) at last visit.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit', 'timeFrame': 'At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Change from baseline in diastolic blood pressure (DBP) at last visit.'}, {'measure': 'Number of Participants Per Final Effectiveness Assessment Category at Last Visit', 'timeFrame': 'At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).', 'description': 'Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'type 2 diabetes mellitus in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea\n2. Age = 19 years at enrolment\n3. Patients who have signed on the data release consent form\n\nExclusion criteria:\n\n1. Known hypersensitivity to empagliflozin or any of its excipients\n2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis\n3. Patients with persistent estimated Glomerular Filtration Rate \\<60 mL/min/1.73 m2,end stage renal disease or on dialysis\n4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption\n5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®'}, 'identificationModule': {'nctId': 'NCT02848833', 'briefTitle': 'JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1245.116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JARDIANCE', 'description': 'T2DM with JARDIANCE', 'interventionNames': ['Drug: JARDIANCE 10mg', 'Drug: JARDIANCE 25mg']}], 'interventions': [{'name': 'JARDIANCE 10mg', 'type': 'DRUG', 'description': 'T2DM with JARDIANCE 10mg', 'armGroupLabels': ['JARDIANCE']}, {'name': 'JARDIANCE 25mg', 'type': 'DRUG', 'description': 'MT2DM with JARDIANCE 25mgax', 'armGroupLabels': ['JARDIANCE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}