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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002665-22 | EudraCT Number |
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Change in benefit/risk profile.
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The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with ATTR-CM in Part A | Experimental | Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans. |
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| Subjects with ATTR-CM in Part B | Experimental | Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2315698 (CPHPC) | Drug | GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852. | Session 1: Days 4, 5, 6 and 8 |
| Part A- Session 2: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. | Session 2: Days 3, 4 and 5 |
| Part B: Peak SUV in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV in focal anatomical regions of the heart was planned to be measured. | Days 3, 4 and 6 |
| Part B: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV in focal anatomical regions of the heart was planned to be measured. | Days 3, 4 and 6 |
| Part A- Session 1: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb |
| Measure | Description | Time Frame |
|---|---|---|
| Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented. | Session 1: Days 4, 5, 6 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35152886 | Derived | Wechalekar A, Antoni G, Al Azzam W, Bergstrom M, Biswas S, Chen C, Cheriyan J, Cleveland M, Cookson L, Galette P, Janiczek RL, Kwong RY, Lukas MA, Millns H, Richards D, Schneider I, Solomon SD, Sorensen J, Storey J, Thompson D, van Dongen G, Vugts DJ, Wall A, Wikstrom G, Falk RH. Pharmacodynamic evaluation and safety assessment of treatment with antibodies to serum amyloid P component in patients with cardiac amyloidosis: an open-label Phase 2 study and an adjunctive immuno-PET imaging study. BMC Cardiovasc Disord. 2022 Feb 13;22(1):49. doi: 10.1186/s12872-021-02407-6. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Two participants were enrolled in Part A. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-serum amyloid P component [SAP] treatment) during Part A; hence, no participants were enrolled in Part B.
This was a two part study. Part A contains two dosing sessions and Part B contain single dosing session. This study was conducted at a single center in Sweden from 06-April-18 to 20-July-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Anti-SAP | Participants with either wild type or inherited transthyretin amyloidosis restrictive cardiomyopathy (ATTR-CM) were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 milligram (mg) per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg(session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 positron emission tomography (PET) scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb. |
| FG001 | Part B: Anti-SAP | Participants with either wild type or ATTR-CM were planned to undergo one dosing sessions. Participants were planned to be administered 200 mg/mL GSK2315698 via intravenous infusion for 48 hours followed by administration of 100 mg/mL GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants were planned to receive a subcutaneous injection of GSK2315698 thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 2 PET scans were planned to be performed after the end of 89Zr-GSK2398852 infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (up to 26 Days) |
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| Part B (up to 26 Days) |
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The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment) during Part A; hence, no participants were enrolled in Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Anti-SAP | Participants with either wild type or ATTR-CM were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 mg per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb. |
| Units | Counts |
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| Participants |
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| 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 | Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852. | All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4, 5, 6 and 8 |
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AEs and SAEs were collected up to Day 26 of the last session
Safety population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852. AEs and SAEs were not collected in Part B as no participants were enrolled. Data is presented for Part A only as data was not collected in Part B due to the study was terminated during Part A, and Part B was not initiated.
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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 | Part A: Anti-SAP | Participants with either wild type or ATTR-CM were included. Participants underwent two dosing sessions. In each dosing session, participants were administered (dependent on renal function) 20 mg per hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session1) or 490mg (session2) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. There was a minimum of 4 weeks of duration between dosing sessions of anti-SAP mAb. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2017 | Apr 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2019 | Apr 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000709571 | miridesap |
| C000723181 | dezamizumab |
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Part A of the study will include 3 subjects with ATTR-CM who will participate in two dosing sessions and Part B of the study will include 3 subjects with ATTR-CM who will participate in one dosing session. A single dosing session will constitute treatment with carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC), total mass dose (TMD) administration of anti-serum amyloid P (SAP) monoclonal antibody (mAb) consisting of in vivo mixing of a single infusion of unlabeled anti-SAP mAb and a separate infusion of 89Zr-GSK2398852 via a different peripheral venous line, and up to 3 serial PET scanning procedures after administration of 89Zr-GSK2398852.
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| GSK2398852 (unlabeled anti-SAP mAb) | Drug | Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data. |
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| 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb) | Drug | 89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session. |
|
SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. |
| Session 1: Days 4, 5, 6 and 8 |
| Part A- Session 2: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. | Session 2: Days 3, 4 and 5 |
| Part B: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV of whole heart was planned to be measured. | Days 3, 4 and 6 |
| Part B: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of whole heart was planned to be measured. | Days 3, 4 and 6 |
| Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyriod Gland-goitre Hotspot | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented. | Session 1: Days 4 and 6 |
| Part A- Session 2: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented. | Session 2: Days 3, 4 and 5 |
| Part B: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV of focal radioactivity uptake for different organs/tissues was planned to be measured. | Days 3, 4 and 6 |
| Part B: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of focal radioactivity uptake for different organs/tissues was planned to be measured. | Days 3, 4 and 6 |
| Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented. | Session 1: Days 4, 5, 6 and 8 |
| Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyroid Gland-goitre | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented. | Session 1: Days 4 and 6 |
| Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Testes | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented. | Session 1: Days 4, 5 and 8 |
| Part A- Session 2: Mean SUV of Total Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented. | Session 2: Days 3, 4, and 5 |
| Part B: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV of total radioactivity uptake for different organs/tissues was planned to be measured. | Days 3, 4 and 6 |
| Part B: Mean SUV of Total Radioactivity Uptake After an Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of total radioactivity uptake for different organs/tissues was planned to be measured. | Days 3, 4 and 6 |
| Part A: Maximum Concentration in Plasma (Cmax) of Total mAb | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed. | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: Cmax of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A: Time Associated With Cmax (Tmax) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: Tmax of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A: Clearance of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: Clearance of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A: Terminal Half-life (T1/2) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: T1/2 of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A:Area Under the Concentration Time Curve Till Last Observation (AUC[0 to t]) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: AUC(0 to t) of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A: Area Under the Concentration Time Curve Till Time Infinity (AUC[0 to Infinity]) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
| Part B: AUC(0 to Infinity) of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
| Part A: Cmax of 89Zr-GSK2398852 PKs of Radioactivity (Radio-PK) | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part B: Cmax of 89Zr-GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part A: Tmax of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part B: Tmax of 89Zr-GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part A: T1/2 of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part B: T1/2 of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part A: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part B: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part A: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part B: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
| Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852. | Up to Day 26 of the last session |
| Part B: Number of Participants With AEs and SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. | Up to Day 26 |
| Part A: Number of Participants With Skin Rashes | Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: <10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement). | Up to Day 26 of the last session |
| Part B: Number of Participants With Skin Rashes | Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: <10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement). | Up to Day 26 |
| Part A: Number of Participants With Cardiac Adverse Events | The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented. | Up to Day 26 of the last session |
| Part B: Number of Participants With Cardiac Adverse Events | The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported. | Up to Day 26 |
| Part A: Number of Participants With Infusion Related Reactions | Number of participants with any infusion related reactions are presented. | Up to Day 26 of the last session |
| Part B: Number of Participants With Infusion Related Reactions | Number of participants with any infusion related reactions were planned to be reported. | Up to Day 26 |
| Part A: Change From Baseline in Cardiac Troponin T and N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP) | Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26; Session 2: Day 1- Pre-dose, Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26 |
| Part B: Change From Baseline in Cardiac Troponin T and NT-ProBNP | Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Baseline and up to Day 26 |
| Part A: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | 12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal 12-lead ECG Findings | 12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Inpatient Cardiac Telemetry | Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Inpatient Cardiac Telemetry | Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Outpatient Cardiac Telemetry | Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Outpatient Cardiac Telemetry | Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- <90 and >180 millimeters of mercury (mmHg), and DBP- <30 and >110 mmHg. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal SBP and DBP | SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Temperature | Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- >37.5 degree celsius. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Temperature | Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Respiratory Rate | Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- <12 and >25 breaths per minute. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Respiratory Rate | Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Up to Day 26 |
| Part A: Number of Participants With Abnormal Pulse Rate | Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- <35 and >140 beats per minute (bpm). | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Pulse Rate | Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Up to Day 26 |
| Part A: Number of Participants With New Abnormal Physical Examination Findings | A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen). | Session 1: At screening (within 35 days of Anti-SAP treatment of session 1), Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11; Session 2: Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11 |
| Part B: Number of Participants With New Abnormal Physical Examination Findings | A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen). | At screening (within 35 days of Anti-SAP treatment), Days 1, 3, 5, 8 and 11 |
| Part A: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Blood samples were planned to be collected to analyze the hematology parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were planned to be collected to analyze the hematology parameter. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were planned to be collected to analyze the hematology parameter. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were planned to be collected to analyze the hematology parameter. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were planned to be collected to analyze the hematology parameter. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes | Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes | Blood samples were planned to be collected to analyze the hematology parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea | Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea | Blood samples were planned to be collected to analyze the chemistry parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Chemistry Parameters: Albumin, Protein | Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Chemistry Parameters: Albumin, Protein | Blood samples were planned to be collected to analyze the chemistry parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Chemistry Parameters: ALP, ALT, AST | Blood samples were planned to be collected to analyze the chemistry parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine | Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
| Part B: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine | Blood samples were planned to be collected to analyze the chemistry parameters. | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
| Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones | Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones. | Up to Day 26 of the last session |
| Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen | Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen. | Up to Day 26 of the last session |
| Part B: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones | Urine samples were planned to be collected to analyze the urinalysis parameters. | Up to Day 26 |
| Part B: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen | Urine samples were planned to be collected to analyze the urinalysis parameters. | Up to Day 26 |
| NOT COMPLETED |
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| BG001 | Part B: Anti-SAP | Participants with either wild type or ATTR-CM were planned to undergo one dosing sessions. Participants were planned to be administered 200 mg/mL GSK2315698 via intravenous infusion for 48 hours followed by administration of 100 mg/mL GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via two separate intravenous infusion on Day 3. Participants were planned to receive a subcutaneous injection of GSK2315698 thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 2 PET scans were planned to be performed after the end of 89Zr-GSK2398852 infusion. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Participants with either wild type or inherited ATTR-CM were included. In dosing session 1, participants were administered (dependent on renal function) 20 mg/hour or 10 mg/hour GSK2315698 for 48 hours by one intravenous infusion; followed by administration of 70 mg (session 1) GSK2398852 (unlabelled anti-SAP mAb) together with 10 mg of 89Zr-GSK2398852 (up to 37 megabecquerel of radioactive dose) via intravenous infusion on Day 3. Participants also received a subcutaneous injection of GSK2315698 60 mg thrice daily for up to 8 days after administration of unlabelled anti-SAP mAb dose. Up to 3 PET scans were performed after the end of 89Zr-GSK2398852 infusion. |
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| Primary | Part A- Session 2: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 2: Days 3, 4 and 5 |
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| Primary | Part B: Peak SUV in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV in focal anatomical regions of the heart was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Primary | Part B: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV in focal anatomical regions of the heart was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Primary | Part A- Session 1: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. | All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4, 5, 6 and 8 |
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| Primary | Part A- Session 2: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. | All treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 2: Days 3, 4 and 5 |
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| Primary | Part B: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb | SUV of whole heart was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Primary | Part B: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of whole heart was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Secondary | Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4, 5, 6 and 8 |
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| Secondary | Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyriod Gland-goitre Hotspot | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4 and 6 |
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| Secondary | Part A- Session 2: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 2: Days 3, 4 and 5 |
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| Secondary | Part B: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV of focal radioactivity uptake for different organs/tissues was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Secondary | Part B: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of focal radioactivity uptake for different organs/tissues was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Secondary | Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4, 5, 6 and 8 |
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| Secondary | Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyroid Gland-goitre | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4 and 6 |
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| Secondary | Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Testes | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 1: Days 4, 5 and 8 |
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| Secondary | Part A- Session 2: Mean SUV of Total Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented. | All treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Grams per milliliter | Session 2: Days 3, 4, and 5 |
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| Secondary | Part B: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb | SUV of total radioactivity uptake for different organs/tissues was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Secondary | Part B: Mean SUV of Total Radioactivity Uptake After an Anti-SAP mAb Dose Between 200 mg and <=500 mg | SUV of total radioactivity uptake for different organs/tissues was planned to be measured. | All treated Population. Data was not collected as no participants were enrolled in Part B. | Posted | Days 3, 4 and 6 |
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| Secondary | Part A: Maximum Concentration in Plasma (Cmax) of Total mAb | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Nanograms per milliliter | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: Cmax of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A: Time Associated With Cmax (Tmax) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: Tmax of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A: Clearance of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Liters per hour | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: Clearance of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A: Terminal Half-life (T1/2) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: T1/2 of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A:Area Under the Concentration Time Curve Till Last Observation (AUC[0 to t]) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours*nanogram per milliliter | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: AUC(0 to t) of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A: Area Under the Concentration Time Curve Till Time Infinity (AUC[0 to Infinity]) of Total mAb | Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours*nanogram per milliliter | Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7 |
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| Secondary | Part B: AUC(0 to Infinity) of Total mAb | Blood samples were planned to be collected at indicated time points for PK analysis of total mAb. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8 |
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| Secondary | Part A: Cmax of 89Zr-GSK2398852 PKs of Radioactivity (Radio-PK) | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Becquerel per gram | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part B: Cmax of 89Zr-GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part A: Tmax of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part B: Tmax of 89Zr-GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part A: T1/2 of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part B: T1/2 of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
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| Secondary | Part A: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours*Becquerel per gram | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
|
|
|
| Secondary | Part B: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
|
|
| Secondary | Part A: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK | Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Full Range | Hours*Becquerel per gram | Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
|
|
|
| Secondary | Part B: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK | Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter. | PK Population. Data was not collected as no participants were enrolled in Part B. | Posted | Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6 |
|
|
| Secondary | Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With AEs and SAEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Skin Rashes | Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: <10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement). | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Skin Rashes | Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: <10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement). | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Cardiac Adverse Events | The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Cardiac Adverse Events | The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Infusion Related Reactions | Number of participants with any infusion related reactions are presented. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Infusion Related Reactions | Number of participants with any infusion related reactions were planned to be reported. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Change From Baseline in Cardiac Troponin T and N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP) | Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Nanograms per liter | Session 1: Baseline (Day 1 Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26; Session 2: Day 1- Pre-dose, Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Cardiac Troponin T and NT-ProBNP | Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline and up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | 12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal 12-lead ECG Findings | 12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Inpatient Cardiac Telemetry | Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal Inpatient Cardiac Telemetry | Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Outpatient Cardiac Telemetry | Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal Outpatient Cardiac Telemetry | Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- <90 and >180 millimeters of mercury (mmHg), and DBP- <30 and >110 mmHg. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal SBP and DBP | SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Temperature | Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- >37.5 degree celsius. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal Temperature | Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Respiratory Rate | Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- <12 and >25 breaths per minute. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal Respiratory Rate | Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With Abnormal Pulse Rate | Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- <35 and >140 beats per minute (bpm). | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
|
|
|
| Secondary | Part B: Number of Participants With Abnormal Pulse Rate | Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| Secondary | Part A: Number of Participants With New Abnormal Physical Examination Findings | A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen). | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Count of Participants | Participants | Session 1: At screening (within 35 days of Anti-SAP treatment of session 1), Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11; Session 2: Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11 |
|
|
|
| Secondary | Part B: Number of Participants With New Abnormal Physical Examination Findings | A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen). | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | At screening (within 35 days of Anti-SAP treatment), Days 1, 3, 5, 8 and 11 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Billion cells per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | Blood samples were planned to be collected to analyze the hematology parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Percentage of red blood cells in blood | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were planned to be collected to analyze the hematology parameter. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were planned to be collected to analyze the hematology parameter. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Picograms | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were planned to be collected to analyze the hematology parameter. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Femtoliter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were planned to be collected to analyze the hematology parameter. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes | Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | 10^12 cells per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
|
|
|
| Secondary | Part B: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes | Blood samples were planned to be collected to analyze the hematology parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
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|
| Secondary | Part A: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea | Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
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|
|
| Secondary | Part B: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea | Blood samples were planned to be collected to analyze the chemistry parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
|
|
| Secondary | Part A: Change From Baseline in Chemistry Parameters: Albumin, Protein | Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
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|
|
| Secondary | Part B: Change From Baseline in Chemistry Parameters: Albumin, Protein | Blood samples were planned to be collected to analyze the chemistry parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
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|
| Secondary | Part A: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | International units per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
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|
| Secondary | Part B: Change From Baseline in Chemistry Parameters: ALP, ALT, AST | Blood samples were planned to be collected to analyze the chemistry parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
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|
| Secondary | Part A: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine | Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26 |
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|
|
| Secondary | Part B: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine | Blood samples were planned to be collected to analyze the chemistry parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26 |
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|
| Secondary | Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones | Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
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|
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| Secondary | Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen | Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 26 of the last session |
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| Secondary | Part B: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones | Urine samples were planned to be collected to analyze the urinalysis parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
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|
| Secondary | Part B: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen | Urine samples were planned to be collected to analyze the urinalysis parameters. | Safety Population. Data was not collected as no participants were enrolled in Part B. | Posted | Up to Day 26 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| Restless legs syndrome | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Urticarial vasculitis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Session2:Blood pool left atrium,Day5 |
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| Session2:Blood pool left ventricle,Day3 |
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| Session2:Blood pool left ventricle,Day4 |
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| Session2:Blood pool left ventricle,Day5 |
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| Session2:Blood pool right ventricle,Day3 |
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| Session2:Blood pool right ventricle,Day4 |
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| Session2:Blood pool right ventricle,Day5 |
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| Session2:Left ventricle wall-high uptake,Day3 |
|
| Session2:Left ventricle wall-high uptake,Day4 |
|
| Session2: Left ventricle wall-high uptake,Day5 |
|
| Session2:Left ventricle wall-low uptake,Day3 |
|
| Session2:Left ventricle wall-low uptake,Day4 |
|
| Session2: Left ventricle wall-low uptake,Day5 |
|
| Session2: Mid septum-high uptake,Day3 |
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| Session2: Mid septum-high uptake,Day4 |
|
| Session2: Mid septum-high uptake,Day5 |
|
| Session2: Mid septum-low uptake,Day3 |
|
| Session2: Mid septum-low uptake,Day4 |
|
| Session2: Mid septum-low uptake,Day5 |
|
|
| Session 1: Day 6, n=1 |
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|
| Session 1: Day 8, n=1 |
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|
| Session 2: Day 5 |
|
|
| Session1:Abdominal skin,Day 6,n=1 |
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|
| Session1:Abdominal skin,Day 8,n=1 |
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| Session1:Skin of the back,Day 4,n=2 |
|
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| Session1:Skin of the back,Day 5,n=1 |
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| Session1:Skin of the back,Day 6,n=1 |
|
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| Session1:Skin of the back,Day 8,n=1 |
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|
| Session2:Thyroid gland-goitre hotspot,Day 5 |
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| Session2:Abdominal skin,Day 3 |
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| Session2:Abdominal skin,Day 4 |
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| Session2:Abdominal skin,Day 5 |
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| Session2:Skin of the back,Day 3 |
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| Session2:Skin of the back,Day 4 |
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| Session2:Skin of the back,Day 5 |
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|
| Session1:Adrenal gland,Day 6,n=1 |
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| Session1:Adrenal gland,Day 8,n=1 |
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| Session1: Aorta,Day 4,n=2 |
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| Session1: Aorta,Day 5,n=1 |
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|
| Session1: Aorta,Day 6,n=1 |
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| Session1: Aorta,Day 8,n=1 |
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| Session1: Bone marrow,Day 4,n=2 |
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| Session1: Bone marrow,Day 5,n=1 |
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| Session1: Bone marrow,Day 6,n=1 |
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| Session1: Bone marrow,Day 8,n=1 |
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| Session1: Kidney,Day 4,n=2 |
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| Session1: Kidney,Day 5,n=1 |
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|
| Session1: Kidney,Day 6,n=1 |
|
|
| Session1: Kidney,Day 8,n=1 |
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|
| Session1:Liver,Day 4,n=2 |
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|
| Session1:Liver,Day 5,n=1 |
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|
| Session1:Liver,Day 6,n=1 |
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|
| Session1:Liver,Day 8,n=1 |
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|
| Session1: Spleen,Day 4,n=2 |
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| Session1: Spleen,Day 5,n=1 |
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|
| Session1: Spleen,Day 6,n=1 |
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|
| Session1: Spleen,Day 8,n=1 |
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|
| Session1:Abdominal region,Day 4,n=2 |
|
|
| Session1:Abdominal region,Day 5,n=1 |
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| Session1:Abdominal region,Day 6,n=1 |
|
|
| Session1:Abdominal region,Day 8,n=1 |
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| Session1: Brain,Day 4,n=2 |
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|
| Session1: Brain,Day 5,n=1 |
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|
| Session1: Brain,Day 6,n=1 |
|
|
| Session1: Brain,Day 8,n=1 |
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|
| Session1: Lung,Day 4,n=2 |
|
|
| Session1: Lung,Day 5,n=1 |
|
|
| Session1: Lung,Day 6,n=1 |
|
|
| Session1: Lung,Day 8,n=1 |
|
|
| Session1:Parotid gland,Day 4,n=2 |
|
|
| Session1:Parotid gland,Day 5,n=1 |
|
|
| Session1:Parotid gland,Day 6,n=1 |
|
|
| Session1:Parotid gland,Day 8,n=1 |
|
|
| Session1: Thigh,Day 4,n=2 |
|
|
| Session1: Thigh,Day 5,n=1 |
|
|
| Session1: Thigh,Day 6,n=1 |
|
|
| Session1: Thigh,Day 8,n=1 |
|
|
|
| Session1: Day 8 |
|
| Session2: Adrenal gland,Day 5 |
|
| Session2: Aorta,Day 3 |
|
| Session2: Aorta,Day 4 |
|
| Session2: Aorta,Day 5 |
|
| Session2: Bone marrow,Day 3 |
|
| Session2: Bone marrow,Day 4 |
|
| Session2: Bone marrow,Day 5 |
|
| Session2: Kidney,Day 3 |
|
| Session2: Kidney,Day 4 |
|
| Session2: Kidney,Day 5 |
|
| Session2:Liver,Day 3 |
|
| Session2:Liver,Day 4 |
|
| Session2:Liver,Day 5 |
|
| Session2: Spleen,Day 3 |
|
| Session2: Spleen,Day 4 |
|
| Session2: Spleen,Day 5 |
|
| Session2:Abdominal region,Day 3 |
|
| Session2:Abdominal region,Day 4 |
|
| Session2:Abdominal region,Day 5 |
|
| Session2: Brain,Day 3 |
|
| Session2: Brain,Day 4 |
|
| Session2: Brain,Day 5 |
|
| Session2: Lung,Day 3 |
|
| Session2: Lung,Day 4 |
|
| Session2: Lung,Day 5 |
|
| Session2:Parotid gland,Day 3 |
|
| Session2:Parotid gland,Day 4 |
|
| Session2:Parotid gland,Day 5 |
|
| Session2: Thigh,Day 3 |
|
| Session2: Thigh,Day 4 |
|
| Session2: Thigh,Day 5 |
|
| Session2:Thyroid gland-goitre,Day 3 |
|
| Session2:Thyroid gland-goitre,Day 4 |
|
| Session2:Thyroid gland-goitre,Day 5 |
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
|
| Troponin T:Session1-Day4,n=2 |
|
|
| Troponin T:Session1-Day5,n=2 |
|
|
| Troponin T:Session1-Day6,n=2 |
|
|
| Troponin T:Session1-Day7,n=2 |
|
|
| Troponin T:Session1-Day8,n=2 |
|
|
| Troponin T:Session1-Day9,n=2 |
|
|
| Troponin T:Session1-Day10,n=2 |
|
|
| Troponin T:Session1-Day26,n=2 |
|
|
| Troponin T:Session2-Day1-pre-dose,n=1 |
|
|
| Troponin T:Session2-Day2,n=1 |
|
|
| Troponin T:Session2-Day3,n=1 |
|
|
| Troponin T:Session2-Day4,n=1 |
|
|
| Troponin T:Session2-Day5,n=1 |
|
|
| Troponin T:Session2-Day6,n=1 |
|
|
| Troponin T:Session2-Day7,n=1 |
|
|
| Troponin T:Session2-Day8,n=1 |
|
|
| Troponin T:Session2-Day9,n=1 |
|
|
| Troponin T:Session2-Day10,n=1 |
|
|
| Troponin T:Session2-Day26,n=1 |
|
|
| NT-ProBNP:Session1-Day2,n=2 |
|
|
| NT-ProBNP:Session1-Day3,n=2 |
|
|
| NT-ProBNP:Session1-Day4,n=2 |
|
|
| NT-ProBNP:Session1-Day5,n=2 |
|
|
| NT-ProBNP:Session1-Day6,n=2 |
|
|
| NT-ProBNP:Session1-Day7,n=2 |
|
|
| NT-ProBNP:Session1-Day8,n=2 |
|
|
| NT-ProBNP:Session1-Day9,n=2 |
|
|
| NT-ProBNP:Session1-Day10,n=2 |
|
|
| NT-ProBNP:Session1-Day26,n=2 |
|
|
| NT-ProBNP:Session2-Day1-pre-dose,n=1 |
|
|
| NT-ProBNP:Session2-Day2,n=1 |
|
|
| NT-ProBNP:Session2-Day3,n=1 |
|
|
| NT-ProBNP:Session2-Day4,n=1 |
|
|
| NT-ProBNP:Session2-Day5,n=1 |
|
|
| NT-ProBNP:Session2-Day6,n=1 |
|
|
| NT-ProBNP:Session2-Day7,n=1 |
|
|
| NT-ProBNP:Session2-Day8,n=1 |
|
|
| NT-ProBNP:Session2-Day9,n=1 |
|
|
| NT-ProBNP:Session2-Day10,n=1 |
|
|
| NT-ProBNP:Session2-Day26,n=1 |
|
|
|
| Session1:Day 3,n=2 |
|
|
| Session 1:Day 5,n=2 |
|
|
| Session1:Day 8,n=2 |
|
|
| Session1:Day 11,n=2 |
|
|
| Session2:Day 1 Pre-dose,n=1 |
|
|
| Session2:Day 3,n=1 |
|
|
| Session2:Day 5,n=1 |
|
|
| Session2:Day 8,n=1 |
|
|
| Session2:Day 11,n=1 |
|
|
|
| Session 1: Basophils, Day 7, n=2 |
|
|
| Session 1: Basophils, Day 10, n=2 |
|
|
| Session 1: Basophils, Day 26, n=2 |
|
|
| Session 2: Basophils, Day1-pre-dose, n=1 |
|
|
| Session 2: Basophils, Day 3, n=1 |
|
|
| Session 2: Basophils, Day 5, n=1 |
|
|
| Session 2: Basophils, Day 7, n=1 |
|
|
| Session 2: Basophils, Day 10, n=1 |
|
|
| Session 2: Basophils, Day 26, n=1 |
|
|
| Session 1: Eosinophils, Day 3, n=2 |
|
|
| Session 1: Eosinophils, Day 5, n=2 |
|
|
| Session 1: Eosinophils, Day 7, n=2 |
|
|
| Session 1: Eosinophils, Day 10, n=2 |
|
|
| Session 1: Eosinophils, Day 26, n=2 |
|
|
| Session 2: Eosinophils, Day1-pre-dose, n=1 |
|
|
| Session 2: Eosinophils, Day 3, n=1 |
|
|
| Session 2: Eosinophils, Day 5, n=1 |
|
|
| Session 2: Eosinophils, Day 7, n=1 |
|
|
| Session 2: Eosinophils, Day 10, n=1 |
|
|
| Session 2: Eosinophils, Day 26, n=1 |
|
|
| Session 1: Lymphocytes, Day 3, n=2 |
|
|
| Session 1: Lymphocytes, Day 5, n=2 |
|
|
| Session 1: Lymphocytes, Day 7, n=2 |
|
|
| Session 1: Lymphocytes, Day 10, n=2 |
|
|
| Session 1: Lymphocytes, Day 26, n=2 |
|
|
| Session 2: Lymphocytes, Day1-pre-dose, n=1 |
|
|
| Session 2: Lymphocytes, Day 3, n=1 |
|
|
| Session 2: Lymphocytes, Day 5, n=1 |
|
|
| Session 2: Lymphocytes, Day 7, n=1 |
|
|
| Session 2: Lymphocytes, Day 10, n=1 |
|
|
| Session 2: Lymphocytes, Day 26, n=1 |
|
|
| Session 1: Monocytes, Day 3, n=2 |
|
|
| Session 1: Monocytes, Day 5, n=2 |
|
|
| Session 1: Monocytes, Day 7, n=2 |
|
|
| Session 1: Monocytes, Day 10, n=2 |
|
|
| Session 1: Monocytes, Day 26, n=2 |
|
|
| Session 2: Monocytes, Day1-pre-dose, n=1 |
|
|
| Session 2: Monocytes, Day 3, n=1 |
|
|
| Session 2: Monocytes, Day 5, n=1 |
|
|
| Session 2: Monocytes, Day 7, n=1 |
|
|
| Session 2: Monocytes, Day 10, n=1 |
|
|
| Session 2: Monocytes, Day 26, n=1 |
|
|
| Session 1: Neutrophils, Day 3, n=2 |
|
|
| Session 1: Neutrophils, Day 5, n=2 |
|
|
| Session 1: Neutrophils, Day 7, n=2 |
|
|
| Session 1: Neutrophils, Day 10, n=2 |
|
|
| Session 1: Neutrophils, Day 26, n=2 |
|
|
| Session 2: Neutrophils, Day1-pre-dose, n=1 |
|
|
| Session 2: Neutrophils, Day 3, n=1 |
|
|
| Session 2: Neutrophils, Day 5, n=1 |
|
|
| Session 2: Neutrophils, Day 7, n=1 |
|
|
| Session 2: Neutrophils, Day 10, n=1 |
|
|
| Session 2: Neutrophils, Day 26, n=1 |
|
|
| Session 1: Platelets, Day 3, n=2 |
|
|
| Session 1: Platelets, Day 5, n=2 |
|
|
| Session 1: Platelets, Day 7, n=2 |
|
|
| Session 1: Platelets, Day 10, n=2 |
|
|
| Session 1: Platelets, Day 26, n=2 |
|
|
| Session 2: Platelets, Day1-pre-dose, n=1 |
|
|
| Session 2: Platelets, Day 3, n=1 |
|
|
| Session 2: Platelets, Day 5, n=1 |
|
|
| Session 2: Platelets, Day 7, n=1 |
|
|
| Session 2: Platelets, Day 10, n=1 |
|
|
| Session 2: Platelets, Day 26, n=1 |
|
|
|
| Session 1: Day 7, n=2 |
|
|
| Session 1: Day 10, n=2 |
|
|
| Session 1: Day 26, n=2 |
|
|
| Session 2: Day1-pre-dose, n=1 |
|
|
| Session 2: Day 3, n=1 |
|
|
| Session 2: Day 5, n=1 |
|
|
| Session 2: Day 7, n=1 |
|
|
| Session 2: Day 10, n=1 |
|
|
| Session 2: Day 26, n=1 |
|
|
|
| Session 1: Day 7, n=2 |
|
|
| Session 1: Day 10, n=2 |
|
|
| Session 1: Day 26, n=2 |
|
|
| Session 2: Day1-pre-dose, n=1 |
|
|
| Session 2: Day 3, n=1 |
|
|
| Session 2: Day 5, n=1 |
|
|
| Session 2: Day 7, n=1 |
|
|
| Session 2: Day 10, n=1 |
|
|
| Session 2: Day 26, n=1 |
|
|
|
| Session 1: Day 7, n=2 |
|
|
| Session 1: Day 10, n=2 |
|
|
| Session 1: Day 26, n=2 |
|
|
| Session 2: Day1-pre-dose, n=1 |
|
|
| Session 2: Day 3, n=1 |
|
|
| Session 2: Day 5, n=1 |
|
|
| Session 2: Day 7, n=1 |
|
|
| Session 2: Day 10, n=1 |
|
|
| Session 2: Day 26, n=1 |
|
|
|
| Session 1: Day 7, n=2 |
|
|
| Session 1: Day 10, n=2 |
|
|
| Session 1: Day 26, n=2 |
|
|
| Session 2: Day1-pre-dose, n=1 |
|
|
| Session 2: Day 3, n=1 |
|
|
| Session 2: Day 5, n=1 |
|
|
| Session 2: Day 7, n=1 |
|
|
| Session 2: Day 10, n=1 |
|
|
| Session 2: Day 26, n=1 |
|
|
|
| Session 1: Erythrocytes, Day 7, n=2 |
|
|
| Session 1: Erythrocytes, Day 10, n=2 |
|
|
| Session 1: Erythrocytes, Day 26, n=2 |
|
|
| Session 2: Erythrocytes, Day1-Pre-dose, n=1 |
|
|
| Session 2: Erythrocytes, Day 3, n=1 |
|
|
| Session 2: Erythrocytes, Day 5, n=1 |
|
|
| Session 2: Erythrocytes, Day 7, n=1 |
|
|
| Session 2: Erythrocytes, Day 10, n=1 |
|
|
| Session 2: Erythrocytes, Day 26, n=1 |
|
|
| Session 1: Reticulocytes, Day 3, n=2 |
|
|
| Session 1: Reticulocytes, Day 5, n=2 |
|
|
| Session 1: Reticulocytes, Day 7, n=2 |
|
|
| Session 1: Reticulocytes, Day 10, n=2 |
|
|
| Session 1: Reticulocytes, Day 26, n=2 |
|
|
| Session 2: Reticulocytes, Day1-pre-dose, n=1 |
|
|
| Session 2: Reticulocytes, Day 3, n=1 |
|
|
| Session 2: Reticulocytes, Day 5, n=1 |
|
|
| Session 2: Reticulocytes, Day 7, n=1 |
|
|
| Session 2: Reticulocytes, Day 10, n=1 |
|
|
| Session 2: Reticulocytes, Day 26, n=1 |
|
|
|
| Session 1: Glucose, Day 7, n=2 |
|
|
| Session 1: Glucose, Day 10, n=2 |
|
|
| Session 1: Glucose, Day 26, n=2 |
|
|
| Session 2: Glucose, Day1-pre-dose, n=1 |
|
|
| Session 2: Glucose, Day 3, n=1 |
|
|
| Session 2: Glucose, Day 5, n=1 |
|
|
| Session 2: Glucose, Day 7, n=1 |
|
|
| Session 2: Glucose, Day 10, n=1 |
|
|
| Session 2: Glucose, Day 26, n=1 |
|
|
| Session 1: Calcium, Day 3, n=2 |
|
|
| Session 1: Calcium, Day 5, n=2 |
|
|
| Session 1: Calcium, Day 7, n=1 |
|
|
| Session 1: Calcium, Day 10, n=2 |
|
|
| Session 1: Calcium, Day 26, n=2 |
|
|
| Session 2: Calcium, Day1-pre-dose, n=1 |
|
|
| Session 2: Calcium, Day 3, n=1 |
|
|
| Session 2: Calcium, Day 5, n=1 |
|
|
| Session 2: Calcium, Day 7, n=1 |
|
|
| Session 2: Calcium, Day 10, n=1 |
|
|
| Session 2: Calcium, Day 26, n=1 |
|
|
| Session 1: Potassium, Day 3, n=2 |
|
|
| Session 1: Potassium, Day 5, n=2 |
|
|
| Session 1: Potassium, Day 7, n=1 |
|
|
| Session 1: Potassium, Day 10, n=2 |
|
|
| Session 1: Potassium, Day 26, n=2 |
|
|
| Session 2: Potassium, Day1-pre-dose, n=1 |
|
|
| Session 2: Potassium, Day 3, n=1 |
|
|
| Session 2: Potassium, Day 5, n=1 |
|
|
| Session 2: Potassium, Day 7, n=1 |
|
|
| Session 2: Potassium, Day 10, n=1 |
|
|
| Session 2: Potassium, Day 26, n=1 |
|
|
| Session 1: Sodium, Day 3, n=2 |
|
|
| Session 1: Sodium, Day 5, n=2 |
|
|
| Session 1: Sodium, Day 7, n=2 |
|
|
| Session 1: Sodium, Day 10, n=2 |
|
|
| Session 1: Sodium, Day 26, n=2 |
|
|
| Session 2: Sodium, Day1-pre-dose, n=1 |
|
|
| Session 2: Sodium, Day 3, n=1 |
|
|
| Session 2: Sodium, Day 5, n=1 |
|
|
| Session 2: Sodium, Day 7, n=1 |
|
|
| Session 2: Sodium, Day 10, n=1 |
|
|
| Session 2: Sodium, Day 26, n=1 |
|
|
| Session 1: Urea, Day 3, n=2 |
|
|
| Session 1: Urea, Day 5, n=2 |
|
|
| Session 1: Urea, Day 7, n=2 |
|
|
| Session 1: Urea, Day 10, n=2 |
|
|
| Session 1: Urea, Day 26, n=2 |
|
|
| Session 2: Urea, Day1-pre-dose, n=1 |
|
|
| Session 2: Urea, Day 3, n=1 |
|
|
| Session 2: Urea, Day 5, n=1 |
|
|
| Session 2: Urea, Day 7, n=1 |
|
|
| Session 2: Urea, Day 10, n=1 |
|
|
| Session 2: Urea, Day 26, n=1 |
|
|
|
| Session 1: Albumin, Day 7, n=2 |
|
|
| Session 1: Albumin, Day 10, n=2 |
|
|
| Session 1: Albumin, Day 26, n=2 |
|
|
| Session 2: Albumin, Day1-pre-dose, n=1 |
|
|
| Session 2: Albumin, Day 3, n=1 |
|
|
| Session 2: Albumin, Day 5, n=1 |
|
|
| Session 2: Albumin, Day 7, n=1 |
|
|
| Session 2: Albumin, Day 10, n=1 |
|
|
| Session 2: Albumin, Day 26, n=1 |
|
|
| Session 1: Protein, Day 3, n=2 |
|
|
| Session 1: Protein, Day 5, n=2 |
|
|
| Session 1: Protein, Day 7, n=2 |
|
|
| Session 1: Protein, Day 10, n=1 |
|
|
| Session 1: Protein, Day 26, n=2 |
|
|
| Session 2: Protein, Day1-pre-dose, n=1 |
|
|
| Session 2: Protein, Day 3, n=1 |
|
|
| Session 2: Protein, Day 5, n=0 |
|
| Session 2: Protein, Day 7, n=1 |
|
|
| Session 2: Protein, Day 10, n=1 |
|
|
| Session 2: Protein, Day 26, n=1 |
|
|
|
| Session 1: ALP, Day 7, n=1 |
|
|
| Session 1: ALP, Day 10, n=2 |
|
|
| Session 1: ALP, Day 26, n=2 |
|
|
| Session 2: ALP, Day1-pre-dose, n=1 |
|
|
| Session 2: ALP, Day 3, n=1 |
|
|
| Session 2: ALP, Day 5, n=1 |
|
|
| Session 2: ALP, Day 7, n=1 |
|
|
| Session 2: ALP, Day 10, n=1 |
|
|
| Session 2: ALP, Day 26, n=1 |
|
|
| Session 1: ALT, Day 3, n=2 |
|
|
| Session 1: ALT, Day 5, n=2 |
|
|
| Session 1: ALT, Day 7, n=2 |
|
|
| Session 1: ALT, Day 10, n=2 |
|
|
| Session 1: ALT, Day 26, n=2 |
|
|
| Session 2: ALT, Day1-pre-dose, n=1 |
|
|
| Session 2: ALT, Day 3, n=1 |
|
|
| Session 2: ALT, Day 5, n=1 |
|
|
| Session 2: ALT, Day 7, n=1 |
|
|
| Session 2: ALT, Day 10, n=1 |
|
|
| Session 2: ALT, Day 26, n=1 |
|
|
| Session 1: AST, Day 3, n=2 |
|
|
| Session 1: AST, Day 5, n=2 |
|
|
| Session 1: AST, Day 7, n=2 |
|
|
| Session 1: AST, Day 10, n=2 |
|
|
| Session 1: AST, Day 26, n=2 |
|
|
| Session 2: AST, Day1-pre-dose, n=1 |
|
|
| Session 2: AST, Day 3, n=1 |
|
|
| Session 2: AST, Day 5, n=1 |
|
|
| Session 2: AST, Day 7, n=1 |
|
|
| Session 2: AST, Day 10, n=1 |
|
|
| Session 2: AST, Day 26, n=1 |
|
|
|
| Session 1: Direct Bilirubin, Day 7, n=2 |
|
|
| Session 1: Direct Bilirubin, Day 10, n=2 |
|
|
| Session 1: Direct Bilirubin, Day 26, n=2 |
|
|
| Session 2: Direct Bilirubin, Day1-pre-dose, n=1 |
|
|
| Session 2: Direct Bilirubin, Day 3, n=1 |
|
|
| Session 2: Direct Bilirubin, Day 5, n=1 |
|
|
| Session 2: Direct Bilirubin, Day 7, n=1 |
|
|
| Session 2: Direct Bilirubin, Day 10, n=1 |
|
|
| Session 2: Direct Bilirubin, Day 26, n=1 |
|
|
| Session 1: Bilirubin, Day 3, n=2 |
|
|
| Session 1: Bilirubin, Day 5, n=2 |
|
|
| Session 1: Bilirubin, Day 7, n=2 |
|
|
| Session 1: Bilirubin, Day 10, n=2 |
|
|
| Session 1: Bilirubin, Day 26, n=2 |
|
|
| Session 2: Bilirubin, Day1-pre-dose, n=1 |
|
|
| Session 2: Bilirubin, Day 3, n=1 |
|
|
| Session 2: Bilirubin, Day 5, n=1 |
|
|
| Session 2: Bilirubin, Day 7, n=1 |
|
|
| Session 2: Bilirubin, Day 10, n=1 |
|
|
| Session 2: Bilirubin, Day 26, n=1 |
|
|
| Session 1: Creatinine, Day 3, n=2 |
|
|
| Session 1: Creatinine, Day 5, n=2 |
|
|
| Session 1: Creatinine, Day 7, n=2 |
|
|
| Session 1: Creatinine, Day 10, n=2 |
|
|
| Session 1: Creatinine, Day 26, n=2 |
|
|
| Session 2: Creatinine, Day1-pre-dose, n=1 |
|
|
| Session 2: Creatinine, Day 3, n=1 |
|
|
| Session 2: Creatinine, Day 5, n=1 |
|
|
| Session 2: Creatinine, Day 7, n=1 |
|
|
| Session 2: Creatinine, Day 10, n=1 |
|
|
| Session 2: Creatinine, Day 26, n=1 |
|
|