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This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in Japanese participants. In the second part, the safety and tolerability of long-term use of open-label MK-0954E in participants with hypertension will be evaluated. The primary hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese participants with essential hypertension who are not adequately controlled following a 8-week treatment with filter period study drug of MK-954H.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L50/H12.5/A5→L50/H12.5/A5 | Experimental | One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open label extension. |
|
| L50/H12.5→L50/H12.5/A5 | Active Comparator | One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L50/H12.5/A5 | Drug |
|
| |
| L50/H12.5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period | Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. | Baseline and Week 8 |
| Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received. | up to Week 8 |
| Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received. | up to Week 8 |
| Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period | Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. | Baseline and Week 8 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25271811 | Result | Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1. |
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All participants received single-blind losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5) and placebo for L50/H12.5/amlodipine 5 mg (A5) during 8-week Filter Period. A total of 510 entered the Filter Period and 286 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | L50/H12.5/A5→L50/H12.5/A5 | One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension. |
| FG001 | L50/H12.5→L50/H12.5/A5 | One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Treatment (Weeks 1 to 8) |
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| |||||||||||||||||||||
| Extension (Weeks 9 to 52) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | L50/H12.5/A5→L50/H12.5/A5 | One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension. |
| BG001 | L50/H12.5→L50/H12.5/A5 |
| 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 | Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period | Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm. | All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 8 |
|
Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
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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 | L50/H12.5- Double Blind Treatment Period | Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
|
|
| Placebo to L50/H12.5/A5 | Drug |
|
| Placebo to L50/H12.5 | Drug |
|
| up to Week 8 |
| Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received. | up to Week 8 |
| Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm. | up to Week 8 |
| Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized. | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
| Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized. | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
| Percentage of Participants Who Experience 1 or More SAEs- Long Term | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized. | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
| Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized. | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
| Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized. | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
| Lost to Follow-up |
|
| Blood Pressure/Potassium Criteria Met |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| L50/H12.5 |
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received. | All randomized participants who received at least 1 dose of study drug during double-blind treatment period. | Posted | Number | Percentage of Participants | up to Week 8 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received. | All randomized participants who received at least 1 dose of study drug during double-blind treatment period. | Posted | Number | Percentage of Participants | up to Week 8 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received. | All randomized participants who received at least 1 dose of study drug during double-blind treatment period. | Posted | Number | Percentage of Participants | up to Week 8 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received. | All randomized participants who received at least 1 dose of study drug during double-blind treatment period. | Posted | Number | Percentage of Participants | up to Week 8 |
|
|
|
| Primary | Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm. | All randomized participants who received at least 1 dose of study drug during double-blind treatment period. | Posted | Number | Percentage of Participants | up to Week 8 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized. | All randomized participants who received at least 1 dose of study drug during long-term reporting period. | Posted | Number | Percentage of Participants | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized. | All randomized participants who received at least 1 dose of study drug during long-term reporting period. | Posted | Number | Percentage of Participants | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More SAEs- Long Term | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized. | All randomized participants who received at least 1 dose of study drug during long-term reporting period. | Posted | Number | Percentage of Participants | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
|
|
|
| Primary | Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term | An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized. | All randomized participants who received at least 1 dose of study drug during long-term reporting period. | Posted | Number | Percentage of Participants | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
|
|
|
| Primary | Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized. | All randomized participants who received at least 1 dose of study drug during extension period. | Posted | Number | Percentage of Participants | Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 |
|
|
|
| Secondary | Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period | Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. | All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 8 |
|
|
|
|
| 2 |
| 145 |
| 18 |
| 145 |
| EG001 | L50/H12.5/A5 - Double Blind Treatment Period | Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks | 1 | 141 | 10 | 141 |
| EG002 | L50/H12.5/A5→L50/H12.5/A5 - Extension | Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period. | 2 | 134 | 39 | 134 |
| EG003 | L50/H12.5→L50/H12.5/A5 - Extension | Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period. | 4 | 133 | 42 | 133 |
| Colonic polyp | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Enterocele | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Carcinoid tumour of the duodenum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Malignant neoplasm of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.