Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-008 | Other Identifier | MSD |
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 goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Renal Impairment | Experimental | Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1. |
|
| Severe Renal Impairment | Experimental | Participants with severe renal impairment receive a single dose of MK-8527 on Day 1. |
|
| Healthy | Experimental | Healthy participants receive a single dose of MK-8527 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis. | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant. | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Maximum Concentration (Cmax) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose. | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Time to Maximum Concentration (Tmax) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 29 days |
| Number of Participants Who Discontinue Study Due to an AE |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Moderate and Severe RI
Healthy
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants
Moderate and Severe RI
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research by Design ( Site 0001) | Chicago | Illinois | 60643 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Healthy participants received a single dose of MK-8527 on Day 1. |
| FG001 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of MK-8527 on Day 1. |
| FG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of MK-8527 on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Healthy participants received a single dose of MK-8527 on Day 1. |
| BG001 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of MK-8527 on Day 1. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received the study drug | Posted | Count of Participants | Participants | Up to approximately 29 days |
|
up to approximately 30 days
The population analyzed includes all participants who received the study drug
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 | Moderate Renal Impairment | Participants with moderate renal impairment received a single dose of MK-8527 on Day 1. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.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 | Dec 11, 2023 | Jan 28, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma |
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz). |
| Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Apparent Clearance (CL/F) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf). | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz). | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Up to approximately 29 days |
| AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs) | Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
| AUC0-inf of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant. | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
| Cmax of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Cmax was defined as the maximum observed concentration of MK-8527-TP after the administration of a given dose. | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
| Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the C168 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C168 of MK-8527-TP in PBMCs was determined. | 168 hours post dose |
| Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment | Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C672 of MK-8527-TP in PBMCs was determined. | 672 hours post dose |
| C672 of MK-8527-TP in PBMCs in Healthy Participants | Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Since ≤ 50% of healthy participants had BLQ values, the BLQ value was set to zero and the median, minimum, and maximum was reported for C672. | 672 hours post dose |
| Tmax of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the Tmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Tmax of MK-8527-TP was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
| T1/2 of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz). | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
| BG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of MK-8527 on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline estimated glomerular filtration rate (eGFR) | Baseline eGFR was obtained by taking the mean of two eGFR values obtained ≥ 72 hours apart during screening. eGFR was calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation. | Mean | Standard Deviation | mL/min |
|
| OG002 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of MK-8527 on Day 1. |
|
|
| Secondary | Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received the study drug | Posted | Count of Participants | Participants | Up to approximately 29 days |
|
|
|
| Secondary | AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs) | Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*hr/10^6 cells | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
|
|
|
|
| Secondary | AUC0-inf of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. The λz could not be determined for 1 participant with Moderate RI and 2 participants with Severe RI, therefore AUC0-inf could not be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*hr/10^6 cells | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
|
|
|
|
| Secondary | Cmax of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Cmax was defined as the maximum observed concentration of MK-8527-TP after the administration of a given dose. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
|
|
|
|
| Secondary | Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the C168 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C168 of MK-8527-TP in PBMCs was determined. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | 168 hours post dose |
|
|
|
|
| Secondary | Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment | Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C672 of MK-8527-TP in PBMCs was determined. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. 1 healthy control participant out of 6 had C672 concentration as below the limit of quantitation (BLQ). Therefore, geometric mean and geometric coefficient of variation were not determined for healthy participants. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/10^6 cells | 672 hours post dose |
|
|
|
| Secondary | C672 of MK-8527-TP in PBMCs in Healthy Participants | Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Since ≤ 50% of healthy participants had BLQ values, the BLQ value was set to zero and the median, minimum, and maximum was reported for C672. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. 1 healthy control participant out of 6 had C672 concentration as below the limit of quantitation (BLQ). THe BLQ value was set as '0' and the median and range is reported for healthy participants. | Posted | Median | Full Range | pmol/10^6 cells | 672 hours post dose |
|
|
|
| Secondary | Tmax of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the Tmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Tmax of MK-8527-TP was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. | Posted | Median | Full Range | hr | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
|
|
|
| Secondary | T1/2 of MK-8527-TP in PBMCs | Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz). | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose |
|
|
|
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model | Posted | Geometric Mean | Geometric Coefficient of Variation | nM·hr | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
|
| Primary | Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM·hr | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
|
| Primary | Maximum Concentration (Cmax) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | hr | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
| Primary | Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz). | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
| Primary | Apparent Clearance (CL/F) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf). | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hr | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
| Primary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma | Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz). | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of MK-8527 on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Healthy | Healthy participants received a single dose of MK-8527 on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
All unpublished information given to Celerion and/or the CRU by the Sponsor shall not be published or disclosed to a third party without the prior written consent of the Sponsor.
The data generated by this study are considered confidential information and the property of the Sponsor. This confidential information may be published only in collaboration with participating personnel from the Sponsor or upon Sponsor's written consent to publish the article.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Geometric Mean Ratio (GMR) |
| 2.71 |
| 2-Sided |
| 90 |
| 1.85 |
| 3.95 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 2.35 |
| 2-Sided |
| 90 |
| 1.76 |
| 3.14 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 2.16 |
| 2-Sided |
| 90 |
| 1.20 |
| 3.86 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 2.19 |
| 2-Sided |
| 90 |
| 1.42 |
| 3.36 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 1.86 |
| 2-Sided |
| 90 |
| 1.50 |
| 2.31 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 2.24 |
| 2-Sided |
| 90 |
| 1.77 |
| 2.85 |
GMR=Severe RI (test)/Healthy (reference) |
| Other |
| Geometric Mean Ratio (GMR) |
| 0.82 |
| 2-Sided |
| 90 |
| 0.64 |
| 1.05 |
GMR= Severe RI (test)/Healthy (reference) |
| Other |