Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-183980 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.
The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.
This multi-center observational trial will be conducted in Japan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trelagliptin 100 mg | Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trelagliptin | Drug | Trelagliptin tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | 36 months |
| Number of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. | Baseline, up to final assessment point (up to Month 36) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with type 2 diabetes mellitus in the routine clinical setting
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled. Participants received trelagliptin as part of a routine medical care.
Participants took part in the survey at 242 investigative sites in Japan, from 1 May 2016 to 31 October 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trelagliptin 100 mg | Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trelagliptin 100 mg | Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. |
| 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 | Number of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | 36 months |
|
|
36 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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 | Trelagliptin 100 mg | Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda (Note: This product was divested to Teijin Pharma Limited in 2023) | +1-877-825-3327 | TrialDisclosures@takeda.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 | Dec 25, 2020 | Oct 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2022 | Oct 23, 2022 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C000595449 | trelagliptin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change From Baseline in Fasting Blood Glucose | The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. | Baseline, up to final assessment point (up to Month 36) |
| Change From Baseline in Fasting Insulin Level | The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36). | Baseline, up to final assessment point (up to Month 36) |
| Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ [fasting glucose (mg/dL) - 63]. | Baseline, up to final assessment point (up to Month 36) |
| Change From Baseline in Fasting Glucagon | The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36). | Baseline, up to final assessment point (up to Month 36) |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Baseline, up to final assessment point (up to Month 36) |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Baseline, up to final assessment point (up to Month 36) |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Baseline, up to final assessment point (up to Month 36) |
| 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 |
|
| Region of Enrollment | All participants were enrolled in Japan. | Count of Participants | Participants |
|
| Duration of Type 2 Diabetes Mellitus | Mean duration between the first diagnosis of type 2 diabetes mellitus and the start of the study was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Smoking Classification | Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Alcohol Classification | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Renal Impairment | Count of Participants | Participants |
|
| Hepatic Impairment | Count of Participants | Participants |
|
| Glycosylated Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percent |
|
| Fasting Blood Glucose | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | milligram (mg)/deciliter (dL) |
|
| Fasting Glucagon | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | picogram (pg)/milliliter (mL) |
|
| Serum Creatinine Value Within 1 Month Before Start of Treatment with the Study Drug | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | mg/dL |
|
| Creatinine Clearance Within 1 Month Before Start of Treatment with the Study Drug | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | mL/minute (min) |
|
| Participants |
|
|
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | 36 months |
|
|
|
| Secondary | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | Percent | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose | The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | mg/dL | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Fasting Insulin Level | The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | microunit/milliliter (mcrU/mL) | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ [fasting glucose (mg/dL) - 63]. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | Percent | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Change From Baseline in Fasting Glucagon | The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | pg/mL | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percent | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percent | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| Secondary | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Number | Percent | Baseline, up to final assessment point (up to Month 36) |
|
|
|
| 24 |
| 3,121 |
| 167 |
| 3,121 |
| 54 |
| 3,121 |
| Diabetic gangrene | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatitis B reactivation | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Biliary neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Carcinoid tumour of the gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Chronic hepatitis | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Postrenal failure | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA/J v24.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Electrocardiogram Q wave abnormal | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Transcatheter aortic valve implantation | Surgical and medical procedures | MedDRA/J v24.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D004700 | Endocrine System Diseases |
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Month 36) |
|
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Final Assessment Point (Up to Month 36) |
|
|