Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JARDIANCE | T2DM with JARDIANCE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE 10mg | Drug | T2DM with JARDIANCE 10mg |
| |
| JARDIANCE 25mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Adverse Events | 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. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
| Percentage of Participants With Adverse Events Relating to Study Drug | 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. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
| Percentage of Participants With Unexpected Adverse Events | 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. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
| Percentage of Participants With Adverse Events of Special Interest | 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. The following are considered as AESIs:
| From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
| Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit | Change from baseline in glycosylated hemoglobin (HbA1c) at last visit. | 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). |
| Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
type 2 diabetes mellitus in Korea
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | JARDIANCE® | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | JARDIANCE® | 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. |
| 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 Any Adverse Events | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
|
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JARDIANCE® | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
Not provided
Not provided
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2017 | Mar 19, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
MT2DM with JARDIANCE 25mgax |
|
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. |
| From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit. |
| At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). |
| Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit | 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). |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit | Change from baseline in fasting plasma glucose (FPG) at last visit. | 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). |
| Change From Baseline in Body Weight at Last Visit | Change from baseline in body weight at last visit. | 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). |
| Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit | Change from baseline in systolic blood pressure (SBP) at last visit. | 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). |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit | Change from baseline in diastolic blood pressure (DBP) at last visit. | 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). |
| Number of Participants Per Final Effectiveness Assessment Category at Last Visit | 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.). | At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). |
| Protocol Violation |
|
| 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 |
|
|
|
| Primary | Percentage of Participants With Adverse Events Relating to Study Drug | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
|
|
|
| Primary | Percentage of Participants With Unexpected Adverse Events | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
|
|
|
| Primary | Percentage of Participants With Adverse Events of Special Interest | 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. The following are considered as AESIs:
| 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
|
|
|
| Primary | Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit | Change from baseline in glycosylated hemoglobin (HbA1c) at last visit. | 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. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | 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). |
|
|
|
|
| Secondary | Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit | Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit. | 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. | Posted | Count of Participants | Participants | At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). |
|
|
|
| Secondary | Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit | 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. | Posted | Count of Participants | Participants | 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). |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit | Change from baseline in fasting plasma glucose (FPG) at last visit. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dl) | 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). |
|
|
|
|
| Secondary | Change From Baseline in Body Weight at Last Visit | Change from baseline in body weight at last visit. | 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. | Posted | Mean | Standard Deviation | kilogram | 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). |
|
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit | Change from baseline in systolic blood pressure (SBP) at last visit. | 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. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 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). |
|
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit | Change from baseline in diastolic blood pressure (DBP) at last visit. | 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. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 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). |
|
|
|
|
| Secondary | Number of Participants Per Final Effectiveness Assessment Category at Last Visit | 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.). | 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. | Posted | Count of Participants | Participants | At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). |
|
|
|
| 0 |
| 3,231 |
| 55 |
| 3,231 |
| 0 |
| 3,231 |
| Angina unstable | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pathologic myopia | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vascular stent stenosis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vascular stent thrombosis | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Appendiceal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Splenic injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cervix inflammation | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Benign neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Unassessable |
|