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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1156-8501 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have essential hypertension and type 2 diabetes mellitus (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in addition to standard care for T2DM.
The study will enroll approximately 380 patients. All participants will receive azilsartan medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a participant's blood pressure (BP) has not reached BP goal of <140/85 mmHg at week 6, azilsartan medoxomil dose will be up-titrated to 80 mg daily.
All participants will be asked to take one tablet at the same time each day throughout the study.
This multi-center trial will be conducted in Asia. The overall time to participate in this study is 14 weeks. Participants will make multiple visits to the clinic, and will be contacted by 14 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan medoxomil | Experimental | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Medoxomil | Drug | Azilsartan medoxomil tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg | Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Up to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | Hong Kong | China | ||||
Participants with a diagnosis of essential hypertension and type 2 diabetes mellitus (T2DM) were enrolled to receive azilsartan medoxomil at a starting dose of 40 mg increased to 80 mg if blood pressure of <140/85 mmHg was not achieved at Week 6.
Participants took part in the study at 34 investigative sites in Hong Kong, Taiwan and Thailand from 13 July 2015 to 25 November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoxomil (Switched) | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Switched includes participants who switched from their baseline hypertension therapy to azilsartan medoxomil. |
| FG001 | Azilsartan Medoxomil (Add-On) | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy. |
| FG002 | Azilsartan Medoxomil (Treatment-Naïve) | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Treatment-naïve includes participants never treated with antihypertensive therapy or participants who did not receive hypertension therapy for at least 4 weeks prior to screening. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who took at least 1 dose of azilsartan medoxomil.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoxomil | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. |
| 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 Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Full analysis set (FAS) included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using last observation carried forward (LOCF) method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
From first dose of study drug up to 14 days after the date of the last dose of study drug (up to 14 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse Events are reported as per dose received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Before Week 6 Azilsartan Medoxomil 40 mg | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
| C521273 | azilsartan |
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| Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg | Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Up to Week 12 |
| Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Weeks 6 and 12 |
| Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With DBP <90 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With BP <130/80 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With SBP <130 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With DBP <80 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Percentage of Participants With BP <140/90 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | Week 12 |
| Change From Baseline in Trough Sitting SBP at Week 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | Baseline and Week 12 |
| Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | Baseline and Week 12 |
| Change From Baseline in DBP at Week 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | Baseline and Week 12 |
| Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | Baseline and Week 12 |
| Changhua County |
| Taiwan |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan County | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Khon Kaen | Thailand |
| Pathum Thani | Thailand |
| Lost to Follow-up |
|
| Voluntary Withdrawal |
|
| Investigator Decision |
|
| Reason not specified |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Here number analyzed is the number of participants who were evaluated for weight at baseline. | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Here number analyzed is the number of participants who were evaluated for BMI at baseline. | Mean | Standard Deviation | kg/m^2 |
|
| Smoking history | Count of Participants | Participants |
|
| Baseline Antihypertensive Treatment Status | Participants were counted more than once according to the antihypertensive treatment status. Antihypertensive treatment includes Angiotensin Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB), Calcium Channel Blocker (CCB), Thiazides and/or other treatments. | Number | participants |
|
| Glycosylated Hemoglobin (HbA1c) | Only 374 participants were evaluated for this baseline characteristic. | Mean | Standard Deviation | mmoL/moL |
|
| OG001 | Azilsartan Medoxomil (Add-On) | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of <140/85 mmHg at Week 6. Add-On includes participants who added azilsartan medoxomil to their baseline hypertension therapy. |
|
|
| Secondary | Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg | Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. | Posted | Number | 99% Confidence Interval | percentage of participants | Up to Week 12 |
|
|
|
| Secondary | Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg | At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg | Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. | Posted | Number | 99% Confidence Interval | percentage of participants | Up to Week 12 |
|
|
|
| Secondary | Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Weeks 6 and 12 |
|
|
|
| Secondary | Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With DBP <90 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With BP <130/80 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With SBP <130 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With DBP <80 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants With BP <140/90 mmHg at Week 12 | Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Number | 99% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| Secondary | Change From Baseline in Trough Sitting SBP at Week 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in DBP at Week 12 | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants | At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement. | FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 12 |
|
|
|
| 4 |
| 380 |
| 0 |
| 380 |
| EG001 | After Week 6 Azilsartan Medoxomil 40 mg | Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for Week 6 up to Week 12. | 3 | 258 | 0 | 258 |
| EG002 | After Week 6 Azilsartan Medoxomil 80 mg | Azilsartan medoxomil 80 mg, tablets, orally, once, daily, for Week 6 up to Week 12. | 1 | 97 | 0 | 97 |
| Cardiac failure | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 19.0 | 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.
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |