Atrophy, Geographic
Conditions
Keywords
age-related macular degeneration, geographic atrophy, dry AMD
Brief summary
The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.
Detailed description
This is a Phase 2a proof of concept study designed to evaluate the safety and efficacy of GSK933776 for the treatment of geographic atrophy secondary to age-related macular degeneration. This is a placebo-controlled parallel-group study that is double masked.
Interventions
DRUGGSK933776
GSK933776
DRUGPlacebo
Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥55 years of age inclusive * Evidence of AMD confirmed by the presence of at least 1 druse ≥125 μm diameter * Well-demarcated GA due to AMD of total area 1.9-17 mm2 measured in the study eye * Best-corrected visual acuity score of ≥ 35 letters (approximately 20/200 Snellen VA equivalent or better) in the study eye
Exclusion criteria
* Additional eye disease in the study eye that could compromise assessment of best-corrected visual acuity or imaging of the posterior pole * History of CNV secondary to AMD in the study eye * Any previous treatment for AMD in the study eye, approved or investigational, with the exception of dietary supplements * Risk of cerebrovascular disease, cerebral hemorrhage or stroke * History of systemic autoimmune disease * Use of platelet anti-aggregants or anti-coagulants (aspirin up to 325 mg/day is allowable, or in subjects allergic or intolerable to aspirin, clopidogrel up to 75 mg/day is allowable) * Use of chronic corticosteroids * Uncontrolled hypertension in spite of antihypertensive medications * Renal or hepatic insufficiency or clinically significant anemia * More than moderate MRI white matter changes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Baseline (BL), 6 months, 12 months and 18 months | Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (\>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit. |
| Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Up to 21 months | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs. |
| Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Up to 21 months | — |
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 21 months | Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: \<85 millimeter of mercury (mmHg) and high: \>160 mmHg and DBP was defined as: low:\<45 mmHg and high: \>100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. |
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit | Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:\< 40 beats per minute (bpm) and high: \>100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. |
| Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit | 12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | At any point from Baseline through follow-up visit. | The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed. |
| Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal | Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. |
| Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | Month 12 and Month 18 | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing \>30, \>=15, \>=10, \>=5 and \<5 letters. |
| The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18 | Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Baseline, 6 months, 12 months and 18 months | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Area of Total hypoAF in Study Eye | Baseline, 6 months, 12 months and 18 months | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Baseline and every month up to Month 18 | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. |
| Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| Clearance (CL) of GSK933776 in Geographic Atrophy Participants | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. |
| Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. |
Countries
Canada, United States
Participant flow
Recruitment details
This study was a parallel-group randomized study consisted of a screening visit, where 240 participants entered the observation period (minimum of 4 months), a Baseline visit at the end of observation phase, where 191 were randomized, and was followed by the treatment period (18 months), and a follow-up visit (3 months) after last dose.
Pre-assignment details
The total duration of participation was approximately 25 months following screening.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo via intravenous infusion | 46 |
| GSK933776 3 mg/kg 3 mg/kg administration of GSK933776 via intravenous infusion | 46 |
| GSK933776 6 mg/kg 6 mg/kg administration of GSK933776 via intravenous infusion | 48 |
| GSK933776 15 mg/kg 15 mg/kg administration of GSK933776 via intravenous infusion | 51 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 8 | 10 | 7 |
| Overall Study | Investigator Discretion | 2 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo | GSK933776 3 mg/kg | GSK933776 6 mg/kg | GSK933776 15 mg/kg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 75.3 Years STANDARD_DEVIATION 9.55 | 77.2 Years STANDARD_DEVIATION 9.09 | 77.5 Years STANDARD_DEVIATION 8.57 | 78.6 Years STANDARD_DEVIATION 7.22 | 77.2 Years STANDARD_DEVIATION 8.63 |
| Race/Ethnicity, Customized African American/African Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 45 Participants | 46 Participants | 48 Participants | 51 Participants | 190 Participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 26 Participants | 27 Participants | 109 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 22 Participants | 24 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 46 | 37 / 46 | 32 / 48 | 37 / 51 |
| serious Total, serious adverse events | 9 / 46 | 11 / 46 | 9 / 48 | 12 / 51 |
Outcome results
Primary
Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye
Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (\>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit.
Time frame: Baseline (BL), 6 months, 12 months and 18 months
Population: Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Screening, n=34, 30, 35, 40 | -0.52 square millimeter (m^2) |
| Placebo | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 6 months, n=34, 30, 35, 39 | 0.95 square millimeter (m^2) |
| Placebo | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 12 months, n=33, 29, 34, 40 | 1.60 square millimeter (m^2) |
| Placebo | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 18 months, n=34, 30, 32, 39 | 2.60 square millimeter (m^2) |
| GSK933776 (3 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 6 months, n=34, 30, 35, 39 | 0.88 square millimeter (m^2) |
| GSK933776 (3 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 12 months, n=33, 29, 34, 40 | 1.81 square millimeter (m^2) |
| GSK933776 (3 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 18 months, n=34, 30, 32, 39 | 2.77 square millimeter (m^2) |
| GSK933776 (3 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Screening, n=34, 30, 35, 40 | -0.94 square millimeter (m^2) |
| GSK933776 (6 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 12 months, n=33, 29, 34, 40 | 1.83 square millimeter (m^2) |
| GSK933776 (6 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 6 months, n=34, 30, 35, 39 | 0.73 square millimeter (m^2) |
| GSK933776 (6 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 18 months, n=34, 30, 32, 39 | 2.88 square millimeter (m^2) |
| GSK933776 (6 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Screening, n=34, 30, 35, 40 | -0.99 square millimeter (m^2) |
| GSK933776 (15 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 18 months, n=34, 30, 32, 39 | 2.99 square millimeter (m^2) |
| GSK933776 (15 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 6 months, n=34, 30, 35, 39 | 0.77 square millimeter (m^2) |
| GSK933776 (15 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Screening, n=34, 30, 35, 40 | -0.96 square millimeter (m^2) |
| GSK933776 (15 mg/kg) | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | 12 months, n=33, 29, 34, 40 | 1.89 square millimeter (m^2) |
90% CI: [-0.71, 0.26]
90% CI: [-0.57, 0.43]
90% CI: [-0.31, 0.71]
90% CI: [-0.33, 0.68]
90% CI: [-0.26, 0.72]
90% CI: [-0.21, 0.77]
90% CI: [-0.66, 0.29]
90% CI: [-0.19, 0.75]
90% CI: [-0.08, 0.86]
Primary
Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)
12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Baseline, n=46, 46, 48, 51 | 1 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 6, n=41, 33, 37, 44 | 0 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS early withdrawal, n=7, 8, 7, 3 | 0 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS follow-up, n=39, 37, 37, 38 | 0 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 12, n=41, 32, 40, 40 | 0 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 18, n=38, 30, 36, 35 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 12, n=41, 32, 40, 40 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 18, n=38, 30, 36, 35 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS early withdrawal, n=7, 8, 7, 3 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS follow-up, n=39, 37, 37, 38 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 6, n=41, 33, 37, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Baseline, n=46, 46, 48, 51 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 6, n=41, 33, 37, 44 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS follow-up, n=39, 37, 37, 38 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Baseline, n=46, 46, 48, 51 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 12, n=41, 32, 40, 40 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS early withdrawal, n=7, 8, 7, 3 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 18, n=38, 30, 36, 35 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS follow-up, n=39, 37, 37, 38 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 12, n=41, 32, 40, 40 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Baseline, n=46, 46, 48, 51 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 18, n=38, 30, 36, 35 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS early withdrawal, n=7, 8, 7, 3 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | ECG:CS Month 6, n=41, 33, 37, 44 | 3 Participants |
Primary
Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)
The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed.
Time frame: At any point from Baseline through follow-up visit.
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/Bicarbonate (less than PCI low) | 10 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (Above PCI high) | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Less than PCI low) | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (Above PCI high) | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (less than PCI low) | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (Above PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (Above PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (Above PCI high) | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (Above PCI high) | 11 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/B icarbonate (AbovePCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (Above PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (less than PCI low) | 2 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (Above the PCI high) | 3 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (less than PCI low) | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (Above PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (Above PCI high) | 1 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (less than PCI low) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (Above PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (less than PCI low) | 4 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Above the PCI high) | 0 Participants |
| Placebo | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (Above PCI high) | 5 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (less than PCI low) | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (less than PCI low) | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (less than PCI low) | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (Above PCI high) | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/Bicarbonate (less than PCI low) | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/B icarbonate (AbovePCI high) | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (Above PCI high) | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (Above PCI high) | 17 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Less than PCI low) | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Above the PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (Above PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (Above the PCI high) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (less than PCI low) | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (Above PCI high) | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/Bicarbonate (less than PCI low) | 9 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Above the PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (less than PCI low) | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (Above PCI high) | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (Above PCI high) | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (less than PCI low) | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (Above the PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (Above PCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (Above PCI high) | 9 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/B icarbonate (AbovePCI high) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (less than PCI low) | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (less than PCI low) | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (Above PCI high) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Alanine Amino Transferase (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Aspartate Amino Transferase (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (less than PCI low) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Calcium (Above PCI high) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/Bicarbonate (less than PCI low) | 6 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | CO2 content/B icarbonate (AbovePCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Creatinine (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (less than PCI low) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Glucose (Above PCI high) | 10 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Potassium (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Less than PCI low) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Sodium (Above the PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hemoglobin (Above the PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (less than PCI low) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Hematocrit (Above PCI high) | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (less than PCI low) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Lymphocytes (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (less than PCI low) | 5 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Total ANC (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (less than PCI low) | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | Platelet count (Above PCI high) | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | WBC count (less than PCI low) | 0 Participants |
Primary
Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported.
Time frame: Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA E | 0 Participants |
| Placebo | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA H | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA H | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA E | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA E | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA H | 6 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA E | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | ARIA H | 4 Participants |
Primary
Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs.
Time frame: Up to 21 months
Population: ITT Population: all participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Non-ocular AEs | 41 Participants |
| Placebo | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Ocular AEs | 12 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Non-ocular AEs | 42 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Ocular AEs | 17 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Non-ocular AEs | 44 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Ocular AEs | 15 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Ocular AEs | 20 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | Non-ocular AEs | 47 Participants |
Primary
Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period
Time frame: Up to 21 months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Non-ocular SAEs | 8 Participants |
| Placebo | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Ocular SAEs | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Ocular SAEs | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Non-ocular SAEs | 11 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Non-ocular SAEs | 9 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Ocular SAEs | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Non-ocular SAEs | 12 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Ocular SAEs | 0 Participants |
Primary
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)
Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:\< 40 beats per minute (bpm) and high: \>100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.
Time frame: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | HR Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 0 Participants |
Primary
Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: \<85 millimeter of mercury (mmHg) and high: \>160 mmHg and DBP was defined as: low:\<45 mmHg and high: \>100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.
Time frame: Up to 21 months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, 0 H:> CCR, n=41, 33, 39, 44 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 3:> CCR, n=45, 46, 48, 50 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, Pre-dose:> CCR, n=41, 32, 40, 44 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, Pre-dose:> CCR, n=37, 31, 35, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, 0 H:> CCR, n=40, 32, 40, 44 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, 0 H:> CCR, n=38, 31, 36, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:> CCR, n=40, 31, 35, 41 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, Pre-dose:> CCR, n=46, 46, 48, 51 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:< CCR, n=40, 31, 35, 41 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, Pre-dose:> CCR, n=38, 31, 36, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, Pre-dose:> CCR, n=39, 30, 38, 41 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, 0 H:> CCR, n=39, 30, 38, 41 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, 0 H:> CCR, n=46, 46, 48, 51 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, 0 H:> CCR, n=38, 31, 39, 38 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, Pre-dose:> CCR, n=44, 44, 44, 51 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, 0 H:> CCR, n=37, 31, 35, 39 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, Pre-dose:> CCR, n=44, 43, 42, 49 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, Pre-dose:> CCR, n=37, 31, 35, 39 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 4, 0 H:< CCR, n=43, 34, 42, 46 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, 0 H:> CCR, n=44, 41, 41, 49 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, 0 H:> CCR, n=37, 31, 35, 39 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 5 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Follow-up:> CCR, n=39, 36, 37, 43 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, 0 H:> CCR, n=42, 35, 40, 46 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, Pre-dose:> CCR, n=43, 36, 42, 46 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Early withdrawal, :> CCR, n=8, 8, 7, 4 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, 0 H:> CCR, n=43, 34, 42, 46 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 13, Pre-dose:< CCR, n=38, 31, 39, 39 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, Pre-dose:> CCR, n=43, 36, 40, 45 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, 0 H:> CCR, n=43, 44, 44, 51 | 3 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 18, General:> CCR, n=36, 31, 33, 39 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General: > CCR, n=46, 46, 48, 51 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, Pre-dose:> CCR, n=43, 36, 40, 45 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, 0 H:> CCR, n=42, 36, 40, 45 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:< CCR, n=37, 30, 34, 48 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, Pre-dose:> CCR, n=43, 35, 40, 44 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, 0 H:> CCR, n=43, 33, 40, 44 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 2:> CCR, n=46, 46, 48, 50 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:> CCR, n=37, 30, 34, 48 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, Pre-dose:> CCR, n=42, 33, 40, 44 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, Pre-dose:> CCR, n=38, 32, 36, 40 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, 0 H:> CCR, n=42, 36, 39, 45 | 2 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 1 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 0 Participants |
| Placebo | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:< CCR, n=41, 33, 40, 44 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, Pre-dose:> CCR, n=38, 32, 36, 40 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, Pre-dose:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 3 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, Pre-dose:> CCR, n=41, 32, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 3:> CCR, n=45, 46, 48, 50 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, Pre-dose:> CCR, n=43, 35, 40, 44 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, 0 H:> CCR, n=42, 35, 40, 46 | 3 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, 0 H:> CCR, n=40, 32, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 13, Pre-dose:< CCR, n=38, 31, 39, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, 0 H:> CCR, n=38, 31, 36, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Early withdrawal, :> CCR, n=8, 8, 7, 4 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, Pre-dose:> CCR, n=43, 36, 42, 46 | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:> CCR, n=40, 31, 35, 41 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:> CCR, n=37, 30, 34, 48 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, Pre-dose:> CCR, n=38, 31, 36, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, 0 H:> CCR, n=41, 33, 39, 44 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:< CCR, n=40, 31, 35, 41 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, Pre-dose:> CCR, n=46, 46, 48, 51 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, 0 H:> CCR, n=43, 33, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 18, General:> CCR, n=36, 31, 33, 39 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, Pre-dose:> CCR, n=39, 30, 38, 41 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, 0 H:> CCR, n=37, 31, 35, 39 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, 0 H:> CCR, n=38, 31, 39, 38 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, Pre-dose:> CCR, n=43, 36, 40, 45 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, 0 H:> CCR, n=39, 30, 38, 41 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:< CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, 0 H:> CCR, n=42, 36, 39, 45 | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, 0 H:> CCR, n=46, 46, 48, 51 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, 0 H:> CCR, n=44, 41, 41, 49 | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, Pre-dose:> CCR, n=42, 33, 40, 44 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, Pre-dose:> CCR, n=44, 44, 44, 51 | 5 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 2:> CCR, n=46, 46, 48, 50 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, 0 H:> CCR, n=43, 44, 44, 51 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, Pre-dose:> CCR, n=43, 36, 40, 45 | 3 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 4, 0 H:< CCR, n=43, 34, 42, 46 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General: > CCR, n=46, 46, 48, 51 | 3 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, Pre-dose:> CCR, n=44, 43, 42, 49 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:< CCR, n=37, 30, 34, 48 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, 0 H:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, 0 H:> CCR, n=42, 36, 40, 45 | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, 0 H:> CCR, n=43, 34, 42, 46 | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Follow-up:> CCR, n=39, 36, 37, 43 | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, Pre-dose:> CCR, n=37, 31, 35, 39 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, Pre-dose:> CCR, n=37, 31, 35, 39 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, Pre-dose:> CCR, n=44, 44, 44, 51 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, Pre-dose:> CCR, n=43, 36, 42, 46 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:< CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, Pre-dose:> CCR, n=38, 32, 36, 40 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:< CCR, n=37, 30, 34, 48 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General: > CCR, n=46, 46, 48, 51 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 2:> CCR, n=46, 46, 48, 50 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 3:> CCR, n=45, 46, 48, 50 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, 0 H:> CCR, n=46, 46, 48, 51 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, 0 H:> CCR, n=43, 44, 44, 51 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, Pre-dose:> CCR, n=44, 43, 42, 49 | 3 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, 0 H:> CCR, n=44, 41, 41, 49 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, 0 H:> CCR, n=42, 35, 40, 46 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, 0 H:> CCR, n=43, 34, 42, 46 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, Pre-dose:> CCR, n=43, 36, 40, 45 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, 0 H:> CCR, n=42, 36, 39, 45 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, Pre-dose:> CCR, n=43, 36, 40, 45 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, 0 H:> CCR, n=42, 36, 40, 45 | 3 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, Pre-dose:> CCR, n=43, 35, 40, 44 | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, 0 H:> CCR, n=43, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, Pre-dose:> CCR, n=42, 33, 40, 44 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, 0 H:> CCR, n=41, 33, 39, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, Pre-dose:> CCR, n=41, 32, 40, 44 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, 0 H:> CCR, n=40, 32, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 3 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:> CCR, n=40, 31, 35, 41 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:< CCR, n=40, 31, 35, 41 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, Pre-dose:> CCR, n=39, 30, 38, 41 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, 0 H:> CCR, n=39, 30, 38, 41 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, 0 H:> CCR, n=38, 31, 39, 38 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, Pre-dose:> CCR, n=38, 31, 36, 39 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, 0 H:> CCR, n=38, 31, 36, 39 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, Pre-dose:> CCR, n=46, 46, 48, 51 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, 0 H:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, Pre-dose:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, 0 H:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:> CCR, n=37, 30, 34, 48 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 18, General:> CCR, n=36, 31, 33, 39 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Early withdrawal, :> CCR, n=8, 8, 7, 4 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Follow-up:> CCR, n=39, 36, 37, 43 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 4, 0 H:< CCR, n=43, 34, 42, 46 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 13, Pre-dose:< CCR, n=38, 31, 39, 39 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, Pre-dose:> CCR, n=37, 31, 35, 39 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:< CCR, n=41, 33, 40, 44 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, Pre-dose:> CCR, n=46, 46, 48, 51 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 15, 0 H:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 3:> CCR, n=45, 46, 48, 50 | 4 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, Pre-dose:> CCR, n=37, 31, 35, 39 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, 0 H:> CCR, n=42, 36, 39, 45 | 4 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 16, 0 H:> CCR, n=37, 31, 35, 39 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 8, Pre-dose:> CCR, n=42, 33, 40, 44 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, 0 H:> CCR, n=43, 33, 40, 44 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 7, Pre-dose:> CCR, n=43, 35, 40, 44 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 9, Pre-dose:> CCR, n=41, 33, 40, 44 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:> CCR, n=37, 30, 34, 48 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, 0 H:> CCR, n=42, 36, 40, 45 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 6, Pre-dose:> CCR, n=43, 36, 40, 45 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, 0 H:< CCR, n=37, 30, 34, 48 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 5, Pre-dose:> CCR, n=43, 36, 40, 45 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, 0 H:> CCR, n=43, 34, 42, 46 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General 2:> CCR, n=46, 46, 48, 50 | 4 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 18, General:> CCR, n=36, 31, 33, 39 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 4, Pre-dose:> CCR, n=43, 36, 42, 46 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, 0 H:> CCR, n=42, 35, 40, 46 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline General: > CCR, n=46, 46, 48, 51 | 5 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Early withdrawal, :> CCR, n=8, 8, 7, 4 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 3, Pre-dose:> CCR, n=44, 37, 42, 46 | 4 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, 0 H:> CCR, n=44, 41, 41, 49 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 13, Pre-dose:< CCR, n=38, 31, 39, 39 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Follow-up:> CCR, n=39, 36, 37, 43 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 2, Pre-dose:> CCR, n=44, 43, 42, 49 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, 0 H:> CCR, n=43, 44, 44, 51 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 4, 0 H:< CCR, n=43, 34, 42, 46 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, Pre-dose:> CCR, n=38, 31, 39, 39 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, 0 H:> CCR, n=39, 30, 38, 41 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 12, Pre-dose:> CCR, n=39, 30, 38, 41 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 1, Pre-dose:> CCR, n=44, 44, 44, 51 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 13, 0 H:> CCR, n=38, 31, 39, 38 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:< CCR, n=40, 31, 35, 41 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, 0 H:> CCR, n=40, 31, 35, 41 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 0, 0 H:> CCR, n=46, 46, 48, 51 | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, Pre-dose:> CCR, n=38, 31, 36, 39 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 11, Pre-dose:> CCR, n=41, 33, 39, 42 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, 0 H:> CCR, n=40, 32, 40, 44 | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 17, Pre-dose:> CCR, n=38, 32, 36, 40 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 14, 0 H:> CCR, n=38, 31, 36, 39 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 10, Pre-dose:> CCR, n=41, 32, 40, 44 | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Month 9, 0 H:> CCR, n=41, 33, 39, 44 | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Month 8, 0 H:> CCR, n=41, 33, 40, 44 | 0 Participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants
Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.
Time frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Population: Pharmacokinetic (PK) Parameter Population: all participants in the ITT Population with derived PK parameters
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK933776 (3 mg/kg) | Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | 16725.96 microgram (mcg)*hours (h)/mL |
| GSK933776 (6 mg/kg) | Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | 29717.17 microgram (mcg)*hours (h)/mL |
| GSK933776 (15 mg/kg) | Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | 69485.24 microgram (mcg)*hours (h)/mL |
Secondary
Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye
Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, 6 months, 12 months and 18 months
Population: Efficacy Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 12 months, n=32, 29, 33, 40 | 1.33 mm^2 |
| Placebo | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 18 months, n=33, 30, 31, 39 | 2.24 mm^2 |
| Placebo | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 6 months, n=33, 30, 34, 39 | 0.81 mm^2 |
| Placebo | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Screening, n=33, 30, 34, 40 | -0.70 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 6 months, n=33, 30, 34, 39 | 0.94 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 12 months, n=32, 29, 33, 40 | 1.74 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Screening, n=33, 30, 34, 40 | -0.62 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 18 months, n=33, 30, 31, 39 | 2.65 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 6 months, n=33, 30, 34, 39 | 0.72 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Screening, n=33, 30, 34, 40 | -0.74 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 18 months, n=33, 30, 31, 39 | 2.41 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 12 months, n=32, 29, 33, 40 | 1.67 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 18 months, n=33, 30, 31, 39 | 3.15 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 12 months, n=32, 29, 33, 40 | 1.87 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Screening, n=33, 30, 34, 40 | -0.74 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | 6 months, n=33, 30, 34, 39 | 0.94 mm^2 |
90% CI: [-0.34, 0.61]
90% CI: [-0.07, 0.89]
90% CI: [-0.06, 0.89]
90% CI: [-0.55, 0.37]
90% CI: [-0.13, 0.8]
90% CI: [-0.3, 0.63]
90% CI: [-0.31, 0.57]
90% CI: [0.1, 0.99]
90% CI: [0.47, 1.36]
Secondary
Change From Baseline in Area of Total hypoAF in Study Eye
Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, 6 months, 12 months and 18 months
Population: Efficacy Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in Area of Total hypoAF in Study Eye | 6 months, n=33, 30, 34, 39 | 0.91 mm^2 |
| Placebo | Change From Baseline in Area of Total hypoAF in Study Eye | Screening, n=33, 30, 34, 40 | -0.65 mm^2 |
| Placebo | Change From Baseline in Area of Total hypoAF in Study Eye | 12 months, n=32, 29, 33, 40 | 1.44 mm^2 |
| Placebo | Change From Baseline in Area of Total hypoAF in Study Eye | 18 months, n=33, 30, 31, 39 | 2.35 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 6 months, n=33, 30, 34, 39 | 1.01 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 12 months, n=32, 29, 33, 40 | 1.90 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | Screening, n=33, 30, 34, 40 | -0.63 mm^2 |
| GSK933776 (3 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 18 months, n=33, 30, 31, 39 | 2.67 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | Screening, n=33, 30, 34, 40 | -0.71 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 6 months, n=33, 30, 34, 39 | 0.83 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 18 months, n=33, 30, 31, 39 | 2.46 mm^2 |
| GSK933776 (6 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 12 months, n=32, 29, 33, 40 | 1.67 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 18 months, n=33, 30, 31, 39 | 2.85 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 12 months, n=32, 29, 33, 40 | 1.64 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | 6 months, n=33, 30, 34, 39 | 0.84 mm^2 |
| GSK933776 (15 mg/kg) | Change From Baseline in Area of Total hypoAF in Study Eye | Screening, n=33, 30, 34, 40 | -1.20 mm^2 |
90% CI: [-0.34, 0.55]
90% CI: [0, 0.9]
90% CI: [-0.12, 0.77]
90% CI: [-0.51, 0.35]
90% CI: [-0.21, 0.66]
90% CI: [-0.32, 0.55]
90% CI: [-0.48, 0.35]
90% CI: [-0.22, 0.62]
90% CI: [0.08, 0.92]
Secondary
Clearance (CL) of GSK933776 in Geographic Atrophy Participants
Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.
Time frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK933776 (3 mg/kg) | Clearance (CL) of GSK933776 in Geographic Atrophy Participants | 14.66 mL/h |
| GSK933776 (6 mg/kg) | Clearance (CL) of GSK933776 in Geographic Atrophy Participants | 14.90 mL/h |
| GSK933776 (15 mg/kg) | Clearance (CL) of GSK933776 in Geographic Atrophy Participants | 16.09 mL/h |
Secondary
Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants
Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.
Time frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK933776 (3 mg/kg) | Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | 11.67 Days |
| GSK933776 (6 mg/kg) | Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | 11.87 Days |
| GSK933776 (15 mg/kg) | Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | 11.27 Days |
Secondary
Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants
Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Time frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Population: PK Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK933776 (3 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Cmax | 82311.15 nanogram (ng)/mL |
| GSK933776 (3 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Ctau | 8551.70 nanogram (ng)/mL |
| GSK933776 (6 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Cmax | 142728.2 nanogram (ng)/mL |
| GSK933776 (6 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Ctau | 15512.19 nanogram (ng)/mL |
| GSK933776 (15 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Cmax | 350716.9 nanogram (ng)/mL |
| GSK933776 (15 mg/kg) | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Ctau | 37589.25 nanogram (ng)/mL |
Secondary
Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18
Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and every month up to Month 18
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 5, n=43,36,39, 39 | -1.2 Scores on a scale | Standard Deviation 9.03 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 4, n=43,36,41,46 | 2.7 Scores on a scale | Standard Deviation 8.32 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 6, n=43,36,39,43 | 0.4 Scores on a scale | Standard Deviation 11.62 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 12, n=39,30,37,41 | -0.9 Scores on a scale | Standard Deviation 13.48 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 6, n=43,36,40,40 | -0.8 Scores on a scale | Standard Deviation 9.9 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 17, n=38,32,36,36 | -3.9 Scores on a scale | Standard Deviation 14.56 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 1, n=44,44,43,51 | 0.8 Scores on a scale | Standard Deviation 5.01 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 7, n=43,36,39,44 | 0.4 Scores on a scale | Standard Deviation 13.15 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 7, n=43,36,40,40 | 0.3 Scores on a scale | Standard Deviation 10.49 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 14, n=38,31,34,39 | -0.3 Scores on a scale | Standard Deviation 13.22 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 11, n=41,33,39,42 | 0.1 Scores on a scale | Standard Deviation 12.57 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 3, n=43,37,41,46 | 1.8 Scores on a scale | Standard Deviation 7.73 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 8, n=42,33,40,40 | -0.0 Scores on a scale | Standard Deviation 11.07 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 2, n=44,43,42,49 | 1.1 Scores on a scale | Standard Deviation 5.61 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 15, n=37,31,34,39 | -1.2 Scores on a scale | Standard Deviation 13.44 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 10, n=41, 32,39,44 | -0.8 Scores on a scale | Standard Deviation 14.22 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 9, n=41,33,40,40 | -0.8 Scores on a scale | Standard Deviation 10.9 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 16, n=37,31,35,35 | -0.6 Scores on a scale | Standard Deviation 10.06 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 2, n=44,43,43,43 | -0.3 Scores on a scale | Standard Deviation 7.09 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 18, n=37,31,33,33 | -3.0 Scores on a scale | Standard Deviation 11.58 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 10, n=41,32,40,40 | 0.0 Scores on a scale | Standard Deviation 11.12 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 15, n=37,31,35,35 | -1.7 Scores on a scale | Standard Deviation 11.13 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 17, n=38,32,35,40 | -2.1 Scores on a scale | Standard Deviation 13.53 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 9, n=41,33,39,44 | -0.8 Scores on a scale | Standard Deviation 12.42 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 11, n=41,33,40,40 | 0.4 Scores on a scale | Standard Deviation 11.69 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 3, n=43,37,42,42 | 0.0 Scores on a scale | Standard Deviation 6.57 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 1, n=44,44,44,44 | 0.7 Scores on a scale | Standard Deviation 4.77 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 13, n=38,31,37,39 | -0.2 Scores on a scale | Standard Deviation 13.62 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 12, n=39,30,38,38 | -1.3 Scores on a scale | Standard Deviation 11.57 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 4, n=43,36,42,42 | 0.9 Scores on a scale | Standard Deviation 7.93 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 5, n=43,36,38,46 | 2.4 Scores on a scale | Standard Deviation 8.13 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 8, n=42,33,39,44 | -0.4 Scores on a scale | Standard Deviation 14.53 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 13, n=38,31,39,39 | 0.7 Scores on a scale | Standard Deviation 8.21 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 16, n=37,31,34,39 | 0.1 Scores on a scale | Standard Deviation 12.27 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 18, n=37,31,32,39 | -1.1 Scores on a scale | Standard Deviation 13.12 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, screening, n=46,45,46,51 | -0.0 Scores on a scale | Standard Deviation 6.74 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 14, n=38,31,35,35 | -1.3 Scores on a scale | Standard Deviation 10.84 |
| Placebo | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, screening, n=46,46,48,48 | 0.2 Scores on a scale | Standard Deviation 5.76 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 14, n=38,31,35,35 | -0.2 Scores on a scale | Standard Deviation 8.12 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 15, n=37,31,35,35 | -1.7 Scores on a scale | Standard Deviation 9.09 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, screening, n=46,46,48,48 | 2.6 Scores on a scale | Standard Deviation 6.31 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 6, n=43,36,39,43 | 3.2 Scores on a scale | Standard Deviation 8.81 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 16, n=37,31,35,35 | -2.1 Scores on a scale | Standard Deviation 8.71 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 17, n=38,32,36,36 | -1.9 Scores on a scale | Standard Deviation 8.33 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 5, n=43,36,38,46 | 3.6 Scores on a scale | Standard Deviation 9.47 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 18, n=37,31,33,33 | -2.2 Scores on a scale | Standard Deviation 10.61 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, screening, n=46,45,46,51 | 1.0 Scores on a scale | Standard Deviation 8.3 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 1, n=44,44,44,44 | 0.3 Scores on a scale | Standard Deviation 5.13 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 3, n=43,37,41,46 | 2.3 Scores on a scale | Standard Deviation 8.01 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 1, n=44,44,43,51 | 1.6 Scores on a scale | Standard Deviation 6.22 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 4, n=43,36,41,46 | 3.6 Scores on a scale | Standard Deviation 7.8 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 13, n=38,31,37,39 | 3.7 Scores on a scale | Standard Deviation 7.92 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 2, n=44,43,43,43 | 1.0 Scores on a scale | Standard Deviation 4.68 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 3, n=43,37,42,42 | 0.5 Scores on a scale | Standard Deviation 7.53 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 16, n=37,31,34,39 | 2.0 Scores on a scale | Standard Deviation 9.42 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 4, n=43,36,42,42 | 1.6 Scores on a scale | Standard Deviation 6.72 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 12, n=39,30,37,41 | 3.2 Scores on a scale | Standard Deviation 8.58 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 5, n=43,36,39, 39 | 0.5 Scores on a scale | Standard Deviation 6.6 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 2, n=44,43,42,49 | 2.3 Scores on a scale | Standard Deviation 7.21 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 6, n=43,36,40,40 | 1.1 Scores on a scale | Standard Deviation 6.91 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 15, n=37,31,34,39 | 1.7 Scores on a scale | Standard Deviation 8.13 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 11, n=41,33,39,42 | 2.5 Scores on a scale | Standard Deviation 7.96 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 7, n=43,36,40,40 | 1.4 Scores on a scale | Standard Deviation 7.04 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 10, n=41, 32,39,44 | 4.2 Scores on a scale | Standard Deviation 7.58 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 8, n=42,33,40,40 | 1.5 Scores on a scale | Standard Deviation 5.94 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 9, n=41,33,40,40 | 1.0 Scores on a scale | Standard Deviation 5.97 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 14, n=38,31,34,39 | 1.8 Scores on a scale | Standard Deviation 11.85 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 9, n=41,33,39,44 | 4.5 Scores on a scale | Standard Deviation 7.12 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 10, n=41,32,40,40 | -0.6 Scores on a scale | Standard Deviation 7.4 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 11, n=41,33,40,40 | 0.1 Scores on a scale | Standard Deviation 6.77 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 17, n=38,32,35,40 | 2.7 Scores on a scale | Standard Deviation 9.55 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 8, n=42,33,39,44 | 3.2 Scores on a scale | Standard Deviation 7.08 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 12, n=39,30,38,38 | -0.4 Scores on a scale | Standard Deviation 6.12 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 18, n=37,31,32,39 | 1.2 Scores on a scale | Standard Deviation 10.01 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 13, n=38,31,39,39 | -0.1 Scores on a scale | Standard Deviation 6.89 |
| GSK933776 (3 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 7, n=43,36,39,44 | 3.5 Scores on a scale | Standard Deviation 8.7 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 12, n=39,30,37,41 | 2.7 Scores on a scale | Standard Deviation 7.36 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 2, n=44,43,42,49 | 1.4 Scores on a scale | Standard Deviation 5.5 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 3, n=43,37,41,46 | 1.2 Scores on a scale | Standard Deviation 6.63 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 4, n=43,36,41,46 | 2.6 Scores on a scale | Standard Deviation 7.95 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 10, n=41, 32,39,44 | 2.4 Scores on a scale | Standard Deviation 8.61 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 17, n=38,32,35,40 | 1.6 Scores on a scale | Standard Deviation 9.32 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, screening, n=46,46,48,48 | 0.6 Scores on a scale | Standard Deviation 7.69 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 1, n=44,44,44,44 | 0.4 Scores on a scale | Standard Deviation 5.02 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 2, n=44,43,43,43 | 1.2 Scores on a scale | Standard Deviation 4.45 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 3, n=43,37,42,42 | 1.0 Scores on a scale | Standard Deviation 5.86 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 4, n=43,36,42,42 | 0.3 Scores on a scale | Standard Deviation 6 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 5, n=43,36,39, 39 | 2.2 Scores on a scale | Standard Deviation 4.88 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 6, n=43,36,40,40 | 1.6 Scores on a scale | Standard Deviation 6.55 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 7, n=43,36,40,40 | 1.1 Scores on a scale | Standard Deviation 8.35 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 8, n=42,33,40,40 | 0.6 Scores on a scale | Standard Deviation 8.26 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 9, n=41,33,40,40 | 1.3 Scores on a scale | Standard Deviation 7.39 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 10, n=41,32,40,40 | 0.7 Scores on a scale | Standard Deviation 10.05 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 11, n=41,33,40,40 | -0.6 Scores on a scale | Standard Deviation 8.87 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 12, n=39,30,38,38 | 0.3 Scores on a scale | Standard Deviation 9.94 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 13, n=38,31,39,39 | -0.9 Scores on a scale | Standard Deviation 9.93 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 14, n=38,31,35,35 | -1.2 Scores on a scale | Standard Deviation 10.46 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 15, n=37,31,35,35 | -2.4 Scores on a scale | Standard Deviation 11.33 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 16, n=37,31,35,35 | -2.2 Scores on a scale | Standard Deviation 12.48 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 17, n=38,32,36,36 | -1.3 Scores on a scale | Standard Deviation 11.85 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 18, n=37,31,33,33 | -3.6 Scores on a scale | Standard Deviation 15.05 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, screening, n=46,45,46,51 | 0.7 Scores on a scale | Standard Deviation 6.81 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 1, n=44,44,43,51 | 0.3 Scores on a scale | Standard Deviation 5.52 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 5, n=43,36,38,46 | 1.5 Scores on a scale | Standard Deviation 8.01 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 6, n=43,36,39,43 | 3.4 Scores on a scale | Standard Deviation 6.55 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 7, n=43,36,39,44 | 3.3 Scores on a scale | Standard Deviation 7.01 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 8, n=42,33,39,44 | 1.2 Scores on a scale | Standard Deviation 7.75 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 9, n=41,33,39,44 | 2.7 Scores on a scale | Standard Deviation 7.28 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 11, n=41,33,39,42 | 1.0 Scores on a scale | Standard Deviation 9.05 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 13, n=38,31,37,39 | 1.8 Scores on a scale | Standard Deviation 7.15 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 14, n=38,31,34,39 | 2.9 Scores on a scale | Standard Deviation 7.65 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 15, n=37,31,34,39 | 2.3 Scores on a scale | Standard Deviation 7.28 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 16, n=37,31,34,39 | 2.9 Scores on a scale | Standard Deviation 8.42 |
| GSK933776 (6 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 18, n=37,31,32,39 | 2.5 Scores on a scale | Standard Deviation 8.98 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 13, n=38,31,39,39 | -4.2 Scores on a scale | Standard Deviation 9.79 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 15, n=37,31,34,39 | 2.3 Scores on a scale | Standard Deviation 6.45 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 7, n=43,36,39,44 | 1.9 Scores on a scale | Standard Deviation 6.24 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 12, n=39,30,38,38 | -4.4 Scores on a scale | Standard Deviation 9.69 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 11, n=41,33,40,40 | -4.1 Scores on a scale | Standard Deviation 8.92 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 6, n=43,36,39,43 | 2.8 Scores on a scale | Standard Deviation 7.66 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 8, n=42,33,39,44 | 2.6 Scores on a scale | Standard Deviation 8.16 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 10, n=41,32,40,40 | -3.3 Scores on a scale | Standard Deviation 9.86 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 9, n=41,33,40,40 | -2.2 Scores on a scale | Standard Deviation 8.93 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 4, n=43,36,41,46 | 1.1 Scores on a scale | Standard Deviation 6.63 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 9, n=41,33,39,44 | 3.0 Scores on a scale | Standard Deviation 7.59 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 8, n=42,33,40,40 | -3.4 Scores on a scale | Standard Deviation 8.87 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 7, n=43,36,40,40 | -1.7 Scores on a scale | Standard Deviation 7.71 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 6, n=43,36,40,40 | -1.0 Scores on a scale | Standard Deviation 7.8 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 18, n=37,31,32,39 | 0.4 Scores on a scale | Standard Deviation 8.04 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 11, n=41,33,39,42 | 2.7 Scores on a scale | Standard Deviation 7.89 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 5, n=43,36,39, 39 | -2.6 Scores on a scale | Standard Deviation 9.36 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 4, n=43,36,42,42 | -1.4 Scores on a scale | Standard Deviation 8.09 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 2, n=44,43,43,43 | -0.3 Scores on a scale | Standard Deviation 6.38 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 12, n=39,30,37,41 | 0.5 Scores on a scale | Standard Deviation 10.34 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 3, n=43,37,42,42 | -0.0 Scores on a scale | Standard Deviation 6.39 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 1, n=44,44,44,44 | -1.3 Scores on a scale | Standard Deviation 5.14 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 16, n=37,31,34,39 | 2.4 Scores on a scale | Standard Deviation 7.88 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, screening, n=46,46,48,48 | 0.1 Scores on a scale | Standard Deviation 8.09 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 17, n=38,32,35,40 | 1.6 Scores on a scale | Standard Deviation 8.58 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 14, n=38,31,34,39 | 1.9 Scores on a scale | Standard Deviation 7.69 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 13, n=38,31,37,39 | 2.1 Scores on a scale | Standard Deviation 8.64 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 2, n=44,43,42,49 | 1.0 Scores on a scale | Standard Deviation 8.86 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 1, n=44,44,43,51 | -0.8 Scores on a scale | Standard Deviation 7.52 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, screening, n=46,45,46,51 | 0.4 Scores on a scale | Standard Deviation 9.46 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 18, n=37,31,33,33 | -4.4 Scores on a scale | Standard Deviation 9.72 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 17, n=38,32,36,36 | -3.9 Scores on a scale | Standard Deviation 9.48 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 10, n=41, 32,39,44 | 1.2 Scores on a scale | Standard Deviation 9.26 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 5, n=43,36,38,46 | 1.8 Scores on a scale | Standard Deviation 5.79 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 16, n=37,31,35,35 | -3.9 Scores on a scale | Standard Deviation 9.83 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 15, n=37,31,35,35 | -4.0 Scores on a scale | Standard Deviation 9.36 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Fellow eye, month 3, n=43,37,41,46 | 2.0 Scores on a scale | Standard Deviation 6.57 |
| GSK933776 (15 mg/kg) | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Study eye, month 14, n=38,31,35,35 | -3.8 Scores on a scale | Standard Deviation 9.68 |
Secondary
Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye
Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing \>30, \>=15, \>=10, \>=5 and \<5 letters.
Time frame: Month 12 and Month 18
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing > 30 letters | 1 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing <5 | 31 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing <5 | 28 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 5 letters | 8 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 10 letters | 7 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing > 30 letters | 1 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 15 letters | 4 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 15 letters | 3 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 15 letters | 5 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing > 30 letters | 1 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 5 letters | 10 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing > 30 letters | 2 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing <5 | 22 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 5 letters | 15 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 10 letters | 4 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing <5 | 27 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 10 letters | 10 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 15 letters | 3 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 5 letters | 11 Participants |
| Placebo | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 10 letters | 6 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 15 letters | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 15 letters | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing <5 | 23 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 5 letters | 7 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing <5 | 24 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing > 30 letters | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 10 letters | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 5 letters | 7 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing > 30 letters | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 10 letters | 3 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 5 letters | 6 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing <5 | 24 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing > 30 letters | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 15 letters | 1 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 10 letters | 4 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 5 letters | 10 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing <5 | 21 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing > 30 letters | 0 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 15 letters | 2 Participants |
| GSK933776 (3 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 10 letters | 4 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 5 letters | 10 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing <5 | 28 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 15 letters | 6 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing <5 | 22 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing <5 | 31 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing > 30 letters | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 5 letters | 4 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing > 30 letters | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 10 letters | 3 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 15 letters | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing > 30 letters | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 15 letters | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 10 letters | 9 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing > 30 letters | 2 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 15 letters | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 10 letters | 0 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 10 letters | 1 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing <5 | 28 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 5 letters | 11 Participants |
| GSK933776 (6 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 5 letters | 6 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 5 letters | 12 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 5 letters | 14 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing <5 | 30 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 15 letters | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing > 30 letters | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 10 letters | 9 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 15 letters | 5 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing >= 10 letters | 10 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing >= 15 letters | 6 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 5 letters | 11 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing > 30 letters | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 10 letters | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:Study eye, Losing <5 | 27 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing > 30 letters | 0 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing > 30 letters | 1 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 15 letters | 2 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:Study eye, Losing <5 | 27 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing <5 | 30 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M12:fellow eye, Losing >= 10 letters | 3 Participants |
| GSK933776 (15 mg/kg) | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | M18:fellow eye, Losing >= 5 letters | 9 Participants |
Secondary
The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22)
Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18
Population: PD Concentration Population: all participants in the ITT Population with at least one PD sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 3, PD, n=41,39,39, 46 | 675.95 picogram (PG)/ML | Standard Deviation 158.88 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 7 D post M3, n=9,12,14,9 | 701.59 picogram (PG)/ML | Standard Deviation 232.76 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 4, PD, n=39,32,39,44 | 671.16 picogram (PG)/ML | Standard Deviation 207.78 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 6, PD, n=36,31,35,45 | 664.05 picogram (PG)/ML | Standard Deviation 286.35 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 1 H post, n=35,30,32,43 | 745.27 picogram (PG)/ML | Standard Deviation 262.59 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 9, PD, n=38,28,34,42 | 698.54 picogram (PG)/ML | Standard Deviation 231.31 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 3H post, n=37,38,32,43 | 836.20 picogram (PG)/ML | Standard Deviation 429.027 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 5, PD, n=33,28,35, 46 | 951.92 picogram (PG)/ML | Standard Deviation 516.887 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 3 H post, n=35,29,33,37 | 1532.25 picogram (PG)/ML | Standard Deviation 5463.999 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 21 D post M3, n=18,14, 18,19 | 169.91 picogram (PG)/ML | Standard Deviation 368.921 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 18, PD, n=8,29,29,36 | 127.77 picogram (PG)/ML | Standard Deviation 106.936 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 3 H post, n=10,28,27,35 | 109.09 picogram (PG)/ML | Standard Deviation 88.111 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 Baseline, n=45,42,46,48 | 715.69 picogram (PG)/ML | Standard Deviation 237.06 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 1H post, n=40,39,36,44 | 706.74 picogram (PG)/ML | Standard Deviation 159.38 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 3H post, n=40,39,37,43 | 707.00 picogram (PG)/ML | Standard Deviation 168.67 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 14 D post M3, n=9,9,6,14 | 825.32 picogram (PG)/ML | Standard Deviation 197.52 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 21 D post M3, n=23,15, 18,22 | 592.13 picogram (PG)/ML | Standard Deviation 205.75 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 1 H post, n=38,30,37,42 | 681.64 picogram (PG)/ML | Standard Deviation 245.28 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 3 H post, n=38,31,35,41 | 713.41 picogram (PG)/ML | Standard Deviation 213.6 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 5, PD, n=38,29,38,46 | 686.71 picogram (PG)/ML | Standard Deviation 242.2 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 1 H post, n=38,30,37,43 | 671.58 picogram (PG)/ML | Standard Deviation 263.41 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 3 H post, n=38,29,36,43 | 680.31 picogram (PG)/ML | Standard Deviation 233.46 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 3 H post, n=36,30,31,43 | 717.93 picogram (PG)/ML | Standard Deviation 255.49 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 1 H post, n=37,28,34,41 | 749.19 picogram (PG)/ML | Standard Deviation 230.82 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 3 H post, n=37,26,34,40 | 706.89 picogram (PG)/ML | Standard Deviation 259.6 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 12, PD, n=38,30,37,41 | 688.50 picogram (PG)/ML | Standard Deviation 183.35 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 1 H post, n=37,30,34,38 | 687.88 picogram (PG)/ML | Standard Deviation 203.57 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 3 H post, n=37,31,31,37 | 680.21 picogram (PG)/ML | Standard Deviation 221.73 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 15, PD, n=36,27,31,39 | 667.13 picogram (PG)/ML | Standard Deviation 279.48 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 1 H post, n=38,28,32,38 | 674.94 picogram (PG)/ML | Standard Deviation 272.43 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 3 H post, n=36,27,29,36 | 664.14 picogram (PG)/ML | Standard Deviation 321.47 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 18, PD, n=35,28,34,38 | 562.41 picogram (PG)/ML | Standard Deviation 186.57 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 1 H post, n=35,27,33,37 | 603.70 picogram (PG)/ML | Standard Deviation 184.05 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 3 H post, n=34,26,32,37 | 572.09 picogram (PG)/ML | Standard Deviation 161.77 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 Baseline, n=43,37,45,38 | 743.82 picogram (PG)/ML | Standard Deviation 380.653 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 3, PD, n=39,38,37,45 | 785.65 picogram (PG)/ML | Standard Deviation 454.869 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 1H post, n=39,38,33,43 | 1408.61 picogram (PG)/ML | Standard Deviation 3774.763 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 7 D post M3, n=7,11,11,8 | 922.92 picogram (PG)/ML | Standard Deviation 370.492 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 14 D post M3, n=9,11,4,14 | 1068.33 picogram (PG)/ML | Standard Deviation 779.813 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 21 D post M3, n=18,15,16,20 | 811.92 picogram (PG)/ML | Standard Deviation 321.961 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 4, PD, n=35,31,35, | 894.86 picogram (PG)/ML | Standard Deviation 443.914 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 1 H post, n=32,31,33,41 | 885.66 picogram (PG)/ML | Standard Deviation 377.125 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 3 H post, n=32,31,31,40 | 881.00 picogram (PG)/ML | Standard Deviation 347.112 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 1 H post, n=34,28,35,42 | 962.84 picogram (PG)/ML | Standard Deviation 490.933 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 3 H post, n=36,28,34,40 | 893.16 picogram (PG)/ML | Standard Deviation 485.544 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 6, PD, n=34,29,35,45 | 838.42 picogram (PG)/ML | Standard Deviation 425.702 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 1 H post, n=33,28,33,43 | 1566.28 picogram (PG)/ML | Standard Deviation 4065.365 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 3 H post, n=32,29,32,42 | 846.19 picogram (PG)/ML | Standard Deviation 421.98 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 9, PD, n=33,22,33,42 | 609.41 picogram (PG)/ML | Standard Deviation 329.151 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 1 H post, n=33,23,32,40 | 617.63 picogram (PG)/ML | Standard Deviation 339.05 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 3 H post, n= | 1503.09 picogram (PG)/ML | Standard Deviation 4809.095 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 12, PD, n=32,22,33,39 | 565.11 picogram (PG)/ML | Standard Deviation 269.418 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 1 H post, n=37,29,36,40 | 555.39 picogram (PG)/ML | Standard Deviation 296.989 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Unscheduled, n=0,0,0,1 | NA picogram (PG)/ML | — |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 15, PD, n=35,26,30,37 | 461.47 picogram (PG)/ML | Standard Deviation 414.78 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 1 H post, n=30,27,31,37 | 530.88 picogram (PG)/ML | Standard Deviation 392.825 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 3 H post, n=26,25,30,33 | 825.72 picogram (PG)/ML | Standard Deviation 1527.743 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 18, PD, n=27,27,34,38 | 3144.40 picogram (PG)/ML | Standard Deviation 9209.436 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 1 H post, n=28,27,33,37 | 2988.76 picogram (PG)/ML | Standard Deviation 8357.739 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 3 H post, n=28,27,32,36 | 3144.44 picogram (PG)/ML | Standard Deviation 9129.569 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 Baseline, n=38,39,41,20 | 139.90 picogram (PG)/ML | Standard Deviation 173.673 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 3, PD, n=36,38,40, 37 | 167.67 picogram (PG)/ML | Standard Deviation 255.009 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 1H post, n= 35,38,37,37 | 145.58 picogram (PG)/ML | Standard Deviation 230.115 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 3H post, n=36,38,38,35 | 207.98 picogram (PG)/ML | Standard Deviation 345.712 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 7 D post M3, n=9,11,15,6 | 77.61 picogram (PG)/ML | Standard Deviation 34.043 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 14 D post M3, n=8,11,6,9 | 244.51 picogram (PG)/ML | Standard Deviation 277.941 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 4, PD, n=35,33,39, 29 | 195.41 picogram (PG)/ML | Standard Deviation 331.409 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 1 H post, n=33,33,36,30 | 202.80 picogram (PG)/ML | Standard Deviation 338.066 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 3 H post, n=35,32,33,30 | 201.34 picogram (PG)/ML | Standard Deviation 334.588 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 5, PD, n=33,32,39,34 | 186.73 picogram (PG)/ML | Standard Deviation 316.028 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 1 H post, n=33,32,40,32 | 182.94 picogram (PG)/ML | Standard Deviation 293.746 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 3 H post, n=32,31,39,31 | 177.67 picogram (PG)/ML | Standard Deviation 285.526 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 6, PD, n=27,30,38,33 | 218.22 picogram (PG)/ML | Standard Deviation 418.144 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 1 H post, n=29,30,36,32 | 233.29 picogram (PG)/ML | Standard Deviation 401.633 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 3 H post, n=27,32,34,31 | 222.86 picogram (PG)/ML | Standard Deviation 435.218 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 9, PD, n=19,27,37,38 | 191.73 picogram (PG)/ML | Standard Deviation 243.6 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 1 H post, n=18,27,35,38 | 179.70 picogram (PG)/ML | Standard Deviation 212.048 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 3 H post, n=17,24,36,37 | 201.73 picogram (PG)/ML | Standard Deviation 238.311 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 12, PD, n=13,27,37,37 | 200.69 picogram (PG)/ML | Standard Deviation 265.476 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 1 H post, n=14,26,33,34 | 190.76 picogram (PG)/ML | Standard Deviation 246.82 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 3 H post, n=15,27,30,34 | 193.7 picogram (PG)/ML | Standard Deviation 240.465 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 15, PD, n=11,27,30,37 | 255.38 picogram (PG)/ML | Standard Deviation 510.41 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 1 H post, n=11,27,34,36 | 241.82 picogram (PG)/ML | Standard Deviation 469.544 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 3 H post, n=10,26,30,34 | 272.83 picogram (PG)/ML | Standard Deviation 524.796 |
| Placebo | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 1 H post, n=10,28,29,35 | 119.29 picogram (PG)/ML | Standard Deviation 95.689 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 5, PD, n=33,28,35, 46 | 18728.68 picogram (PG)/ML | Standard Deviation 6760.913 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 15, PD, n=36,27,31,39 | 1011.37 picogram (PG)/ML | Standard Deviation 458.087 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 7 D post M3, n=9,11,15,6 | 1697.51 picogram (PG)/ML | Standard Deviation 401.839 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 9, PD, n=19,27,37,38 | 1049.44 picogram (PG)/ML | Standard Deviation 419.011 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 1 H post, n=34,28,35,42 | 23681.97 picogram (PG)/ML | Standard Deviation 7190.39 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 1 H post, n=38,30,37,43 | 106.23 picogram (PG)/ML | Standard Deviation 117.776 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 3H post, n=36,38,38,35 | 1296.12 picogram (PG)/ML | Standard Deviation 438.252 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 14 D post M3, n=9,9,6,14 | 587.33 picogram (PG)/ML | Standard Deviation 364.383 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 3 H post, n=36,28,34,40 | 25711.80 picogram (PG)/ML | Standard Deviation 6767.509 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 3 H post, n=35,32,33,30 | 1313.46 picogram (PG)/ML | Standard Deviation 457.509 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 3 H post, n=15,27,30,34 | 1238.51 picogram (PG)/ML | Standard Deviation 478.369 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 1H post, n= 35,38,37,37 | 1152.92 picogram (PG)/ML | Standard Deviation 420.811 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 6, PD, n=34,29,35,45 | 18801.95 picogram (PG)/ML | Standard Deviation 7605.319 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 1 H post, n=38,28,32,38 | 102.84 picogram (PG)/ML | Standard Deviation 69.049 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 1 H post, n=33,28,33,43 | 22511.14 picogram (PG)/ML | Standard Deviation 7848.044 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 6, PD, n=36,31,35,45 | 944.83 picogram (PG)/ML | Standard Deviation 666.482 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 3, PD, n=36,38,40, 37 | 988.18 picogram (PG)/ML | Standard Deviation 370.001 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 1 H post, n=18,27,35,38 | 1218.78 picogram (PG)/ML | Standard Deviation 390.582 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 3 H post, n=32,29,32,42 | 26457.65 picogram (PG)/ML | Standard Deviation 7860.423 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 7 D post M3, n=9,12,14,9 | 571.23 picogram (PG)/ML | Standard Deviation 445.822 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 Baseline, n=38,39,41,20 | 92.27 picogram (PG)/ML | Standard Deviation 79.938 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 3 H post, n=37,26,34,40 | 172.30 picogram (PG)/ML | Standard Deviation 159.749 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 9, PD, n=33,22,33,42 | 18187.69 picogram (PG)/ML | Standard Deviation 6942.978 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 3 H post, n=36,27,29,36 | 135.58 picogram (PG)/ML | Standard Deviation 78.565 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 3 H post, n=28,27,32,36 | 21691.51 picogram (PG)/ML | Standard Deviation 8999.993 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 1 H post, n=14,26,33,34 | 1211.53 picogram (PG)/ML | Standard Deviation 488.773 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 1 H post, n=33,23,32,40 | 22315.06 picogram (PG)/ML | Standard Deviation 8256.36 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 5, PD, n=38,29,38,46 | 876.62 picogram (PG)/ML | Standard Deviation 587.141 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 18, PD, n=27,27,34,38 | 14266.65 picogram (PG)/ML | Standard Deviation 7931.78 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 3 H post, n=26,25,30,33 | 23509.29 picogram (PG)/ML | Standard Deviation 9303.296 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 1H post, n=40,39,36,44 | 101.59 picogram (PG)/ML | Standard Deviation 88.045 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 1 H post, n=30,27,31,37 | 20158.76 picogram (PG)/ML | Standard Deviation 7147.691 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 3 H post, n=17,24,36,37 | 1420.29 picogram (PG)/ML | Standard Deviation 486.511 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 12, PD, n=32,22,33,39 | 15213.11 picogram (PG)/ML | Standard Deviation 7350.114 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 6, PD, n=27,30,38,33 | 1074.00 picogram (PG)/ML | Standard Deviation 495.245 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 12, PD, n=13,27,37,37 | 916.06 picogram (PG)/ML | Standard Deviation 451.841 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 18, PD, n=35,28,34,38 | 1019.37 picogram (PG)/ML | Standard Deviation 510.656 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 1 H post, n=37,29,36,40 | 21439.13 picogram (PG)/ML | Standard Deviation 9174.242 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 5, PD, n=33,32,39,34 | 978.6 picogram (PG)/ML | Standard Deviation 403.364 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 3 H post, n=35,29,33,37 | 21295.72 picogram (PG)/ML | Standard Deviation 6471.001 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 Baseline, n=45,42,46,48 | 702.63 picogram (PG)/ML | Standard Deviation 278.771 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 15, PD, n=35,26,30,37 | 16852.93 picogram (PG)/ML | Standard Deviation 6707.423 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 12, PD, n=38,30,37,41 | 980.25 picogram (PG)/ML | Standard Deviation 342.607 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 1 H post, n=35,27,33,37 | 94.79 picogram (PG)/ML | Standard Deviation 54.323 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 3 H post, n=38,29,36,43 | 131.86 picogram (PG)/ML | Standard Deviation 128.104 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 1 H post, n=33,33,36,30 | 1095.62 picogram (PG)/ML | Standard Deviation 348.452 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 18, PD, n=8,29,29,36 | 722.52 picogram (PG)/ML | Standard Deviation 381.288 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 3 H post, n=34,26,32,37 | 127.62 picogram (PG)/ML | Standard Deviation 67.299 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 3 H post, n=38,31,35,41 | 113.68 picogram (PG)/ML | Standard Deviation 120.182 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 15, PD, n=11,27,30,37 | 1022.33 picogram (PG)/ML | Standard Deviation 415.974 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 1 H post, n=28,27,33,37 | 18503.81 picogram (PG)/ML | Standard Deviation 9250.829 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 Baseline, n=43,37,45,38 | 819.49 picogram (PG)/ML | Standard Deviation 296.673 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 1 H post, n=11,27,34,36 | 1181.69 picogram (PG)/ML | Standard Deviation 458.696 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Unscheduled, n=0,0,0,1 | NA picogram (PG)/ML | — |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 1 H post, n=29,30,36,32 | 1241.12 picogram (PG)/ML | Standard Deviation 528.261 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 3, PD, n=39,38,37,45 | 18592.94 picogram (PG)/ML | Standard Deviation 5597.893 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 1 H post, n=37,30,34,38 | 87.34 picogram (PG)/ML | Standard Deviation 74.521 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 3 H post, n= | 26238.37 picogram (PG)/ML | Standard Deviation 8950.567 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 1 H post, n=33,32,40,32 | 1214.53 picogram (PG)/ML | Standard Deviation 409.266 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 1H post, n=39,38,33,43 | 22652.19 picogram (PG)/ML | Standard Deviation 6213.219 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 4, PD, n=35,33,39, 29 | 984.70 picogram (PG)/ML | Standard Deviation 329.701 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 3H post, n=37,38,32,43 | 26215.58 picogram (PG)/ML | Standard Deviation 7838.227 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 1 H post, n=10,28,29,35 | 900.42 picogram (PG)/ML | Standard Deviation 434.525 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 9, PD, n=38,28,34,42 | 965.46 picogram (PG)/ML | Standard Deviation 664.425 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 1 H post, n=35,30,32,43 | 98.90 picogram (PG)/ML | Standard Deviation 89.639 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 7 D post M3, n=7,11,11,8 | 44763.87 picogram (PG)/ML | Standard Deviation 6895.501 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 1 H post, n=38,30,37,42 | 95.12 picogram (PG)/ML | Standard Deviation 101.607 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 3 H post, n=10,28,27,35 | 1024.30 picogram (PG)/ML | Standard Deviation 472.32 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 14 D post M3, n=9,11,4,14 | 35763.55 picogram (PG)/ML | Standard Deviation 6062.09 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 3 H post, n=32,31,39,31 | 1351.07 picogram (PG)/ML | Standard Deviation 416.735 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 21 D post M3, n=18,14, 18,19 | 1015.81 picogram (PG)/ML | Standard Deviation 394.872 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 3 H post, n=27,32,34,31 | 1421.14 picogram (PG)/ML | Standard Deviation 545.844 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 21 D post M3, n=18,15,16,20 | 21020.41 picogram (PG)/ML | Standard Deviation 9021.023 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 3 H post, n=37,31,31,37 | 162.41 picogram (PG)/ML | Standard Deviation 231.741 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 4, PD, n=39,32,39,44 | 798.93 picogram (PG)/ML | Standard Deviation 588.94 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 1 H post, n=37,28,34,41 | 187.83 picogram (PG)/ML | Standard Deviation 206.605 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 4, PD, n=35,31,35, | 17268.05 picogram (PG)/ML | Standard Deviation 5857.907 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 21 D post M3, n=23,15, 18,22 | 669.63 picogram (PG)/ML | Standard Deviation 377.229 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 14 D post M3, n=8,11,6,9 | 1599.87 picogram (PG)/ML | Standard Deviation 373.006 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 3H post, n=40,39,37,43 | 142.63 picogram (PG)/ML | Standard Deviation 144.798 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 1 H post, n=32,31,33,41 | 20994.88 picogram (PG)/ML | Standard Deviation 6978.372 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 3 H post, n=10,26,30,34 | 1360.57 picogram (PG)/ML | Standard Deviation 510.374 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 3 H post, n=32,31,31,40 | 24894.01 picogram (PG)/ML | Standard Deviation 7706.804 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 3 H post, n=36,30,31,43 | 127.41 picogram (PG)/ML | Standard Deviation 114.486 |
| GSK933776 (3 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 3, PD, n=41,39,39, 46 | 833.22 picogram (PG)/ML | Standard Deviation 557.283 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 3H post, n=37,38,32,43 | 34779.13 picogram (PG)/ML | Standard Deviation 9115.431 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 1 H post, n=35,30,32,43 | 87.87 picogram (PG)/ML | Standard Deviation 76.15 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 1 H post, n=10,28,29,35 | 1134.77 picogram (PG)/ML | Standard Deviation 439.66 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 3 H post, n=36,30,31,43 | 101.20 picogram (PG)/ML | Standard Deviation 79.938 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 1 H post, n=37,28,34,41 | 93.58 picogram (PG)/ML | Standard Deviation 103.359 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 1 H post, n=33,32,40,32 | 1526.11 picogram (PG)/ML | Standard Deviation 651.944 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 12, PD, n=38,30,37,41 | 724.92 picogram (PG)/ML | Standard Deviation 366.266 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 1 H post, n=37,30,34,38 | 68.86 picogram (PG)/ML | Standard Deviation 77.852 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 3 H post, n=37,31,31,37 | 79.92 picogram (PG)/ML | Standard Deviation 78.323 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 3 H post, n=32,31,39,31 | 1755.13 picogram (PG)/ML | Standard Deviation 741.876 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 15, PD, n=36,27,31,39 | 877.55 picogram (PG)/ML | Standard Deviation 589.463 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 1 H post, n=38,28,32,38 | 92.10 picogram (PG)/ML | Standard Deviation 109.355 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 1 H post, n=11,27,34,36 | 1266.70 picogram (PG)/ML | Standard Deviation 430.67 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 3 H post, n=36,27,29,36 | 120.82 picogram (PG)/ML | Standard Deviation 124.908 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 18, PD, n=35,28,34,38 | 968.23 picogram (PG)/ML | Standard Deviation 582.016 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 6, PD, n=27,30,38,33 | 1711.71 picogram (PG)/ML | Standard Deviation 1502.526 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 1 H post, n=35,27,33,37 | 93.83 picogram (PG)/ML | Standard Deviation 77.725 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 3 H post, n=34,26,32,37 | 103.38 picogram (PG)/ML | Standard Deviation 84.009 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 Baseline, n=43,37,45,38 | 743.81 picogram (PG)/ML | Standard Deviation 406.171 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 3, PD, n=39,38,37,45 | 27957.34 picogram (PG)/ML | Standard Deviation 8921.484 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 1 H post, n=29,30,36,32 | 1835.47 picogram (PG)/ML | Standard Deviation 1447.74 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 7 D post M3, n=7,11,11,8 | 56154.01 picogram (PG)/ML | Standard Deviation 13944 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 14 D post M3, n=9,11,4,14 | 38729.93 picogram (PG)/ML | Standard Deviation 7646.892 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 21 D post M3, n=18,15,16,20 | 35400.30 picogram (PG)/ML | Standard Deviation 7979.633 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 3 H post, n=27,32,34,31 | 2074.12 picogram (PG)/ML | Standard Deviation 1509.886 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 4, PD, n=35,31,35, | 26716.77 picogram (PG)/ML | Standard Deviation 10948.73 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 3 H post, n=32,31,31,40 | 32626.1 picogram (PG)/ML | Standard Deviation 10801.42 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 5, PD, n=33,28,35, 46 | 27358.59 picogram (PG)/ML | Standard Deviation 11742.9 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 1 H post, n=34,28,35,42 | 29660.64 picogram (PG)/ML | Standard Deviation 10276.52 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 9, PD, n=19,27,37,38 | 1650.02 picogram (PG)/ML | Standard Deviation 1809.009 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 3 H post, n=36,28,34,40 | 33735.73 picogram (PG)/ML | Standard Deviation 12433.44 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 3 H post, n=10,26,30,34 | 1488.49 picogram (PG)/ML | Standard Deviation 479.831 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 1 H post, n=33,28,33,43 | 33259.36 picogram (PG)/ML | Standard Deviation 10975.41 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 3 H post, n=32,29,32,42 | 37724.75 picogram (PG)/ML | Standard Deviation 12990.61 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 1 H post, n=18,27,35,38 | 1723.09 picogram (PG)/ML | Standard Deviation 1521.428 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 9, PD, n=33,22,33,42 | 27101.57 picogram (PG)/ML | Standard Deviation 11334.69 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 1 H post, n=33,23,32,40 | 29347.65 picogram (PG)/ML | Standard Deviation 11567.85 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 3 H post, n= | 31788.45 picogram (PG)/ML | Standard Deviation 12230.14 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 12, PD, n=32,22,33,39 | 24193.39 picogram (PG)/ML | Standard Deviation 10117.95 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 3 H post, n=17,24,36,37 | 1857.20 picogram (PG)/ML | Standard Deviation 1642.287 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 1 H post, n=37,29,36,40 | 25724.20 picogram (PG)/ML | Standard Deviation 9073.725 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 3 H post, n=35,29,33,37 | 28771.21 picogram (PG)/ML | Standard Deviation 9392.402 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 18, PD, n=8,29,29,36 | 997.11 picogram (PG)/ML | Standard Deviation 438.328 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 15, PD, n=35,26,30,37 | 22121.87 picogram (PG)/ML | Standard Deviation 7510.438 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 1 H post, n=30,27,31,37 | 26219.44 picogram (PG)/ML | Standard Deviation 7873.201 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 12, PD, n=13,27,37,37 | 1253.07 picogram (PG)/ML | Standard Deviation 566.682 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 3 H post, n=26,25,30,33 | 29785.49 picogram (PG)/ML | Standard Deviation 9191.623 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 18, PD, n=27,27,34,38 | 21134.85 picogram (PG)/ML | Standard Deviation 8638.106 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 1 H post, n=28,27,33,37 | 24124.61 picogram (PG)/ML | Standard Deviation 7723.055 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 3 H post, n=28,27,32,36 | 28580.63 picogram (PG)/ML | Standard Deviation 8684.78 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 1 H post, n=14,26,33,34 | 1383.67 picogram (PG)/ML | Standard Deviation 605.187 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 Baseline, n=38,39,41,20 | 99.86 picogram (PG)/ML | Standard Deviation 85.958 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 1H post, n= 35,38,37,37 | 1589.49 picogram (PG)/ML | Standard Deviation 629.616 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 3H post, n=36,38,38,35 | 1672.97 picogram (PG)/ML | Standard Deviation 664.08 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 3 H post, n=15,27,30,34 | 1489.97 picogram (PG)/ML | Standard Deviation 519.535 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 7 D post M3, n=9,11,15,6 | 2022.63 picogram (PG)/ML | Standard Deviation 897.848 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 1H post, n=40,39,36,44 | 86.57 picogram (PG)/ML | Standard Deviation 76.641 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 3H post, n=40,39,37,43 | 92.22 picogram (PG)/ML | Standard Deviation 80.565 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 21 D post M3, n=23,15, 18,22 | 730.61 picogram (PG)/ML | Standard Deviation 419.034 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 14 D post M3, n=8,11,6,9 | 1608.36 picogram (PG)/ML | Standard Deviation 360.506 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 21 D post M3, n=18,14, 18,19 | 1559.20 picogram (PG)/ML | Standard Deviation 469.99 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 9, PD, n=38,28,34,42 | 731.34 picogram (PG)/ML | Standard Deviation 460.298 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 3 H post, n=37,26,34,40 | 101.28 picogram (PG)/ML | Standard Deviation 103.129 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 1H post, n=39,38,33,43 | 31669.84 picogram (PG)/ML | Standard Deviation 9225.846 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 1 H post, n=32,31,33,41 | 29940.66 picogram (PG)/ML | Standard Deviation 10073.83 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 6, PD, n=34,29,35,45 | 30073.49 picogram (PG)/ML | Standard Deviation 11286.35 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 4, PD, n=35,33,39, 29 | 1381.96 picogram (PG)/ML | Standard Deviation 666.242 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Unscheduled, n=0,0,0,1 | NA picogram (PG)/ML | — |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 3, PD, n=36,38,40, 37 | 1523.72 picogram (PG)/ML | Standard Deviation 662.292 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 3 H post, n=10,28,27,35 | 1326.97 picogram (PG)/ML | Standard Deviation 491.829 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 1 H post, n=33,33,36,30 | 1541.21 picogram (PG)/ML | Standard Deviation 657.964 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 Baseline, n=45,42,46,48 | 729.12 picogram (PG)/ML | Standard Deviation 260.094 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 3, PD, n=41,39,39, 46 | 721.04 picogram (PG)/ML | Standard Deviation 436.777 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 15, PD, n=11,27,30,37 | 1109.96 picogram (PG)/ML | Standard Deviation 467.439 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 7 D post M3, n=9,12,14,9 | 438.53 picogram (PG)/ML | Standard Deviation 270.154 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 14 D post M3, n=9,9,6,14 | 357.47 picogram (PG)/ML | Standard Deviation 228.729 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 3 H post, n=35,32,33,30 | 1714.54 picogram (PG)/ML | Standard Deviation 689.4 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 4, PD, n=39,32,39,44 | 763.67 picogram (PG)/ML | Standard Deviation 468.654 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 1 H post, n=38,30,37,42 | 114.68 picogram (PG)/ML | Standard Deviation 142.473 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 3 H post, n=38,31,35,41 | 104.79 picogram (PG)/ML | Standard Deviation 85.438 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 5, PD, n=38,29,38,46 | 725.24 picogram (PG)/ML | Standard Deviation 432.365 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 5, PD, n=33,32,39,34 | 1422.10 picogram (PG)/ML | Standard Deviation 620.253 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 1 H post, n=38,30,37,43 | 113.36 picogram (PG)/ML | Standard Deviation 114.519 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 3 H post, n=38,29,36,43 | 99.54 picogram (PG)/ML | Standard Deviation 87.204 |
| GSK933776 (6 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 6, PD, n=36,31,35,45 | 786.00 picogram (PG)/ML | Standard Deviation 395.099 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 3 H post, n=15,27,30,34 | 1411.51 picogram (PG)/ML | Standard Deviation 593.534 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 3 H post, n=32,31,31,40 | 37516.27 picogram (PG)/ML | Standard Deviation 10955.53 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 3 H post, n=32,31,39,31 | 1696.91 picogram (PG)/ML | Standard Deviation 708.505 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 1H post, n=40,39,36,44 | 73.29 picogram (PG)/ML | Standard Deviation 115.732 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 3 H post, n=27,32,34,31 | 1723.03 picogram (PG)/ML | Standard Deviation 790.928 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 15, PD, n=36,27,31,39 | 451.65 picogram (PG)/ML | Standard Deviation 310.992 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 3H post, n=40,39,37,43 | 67.42 picogram (PG)/ML | Standard Deviation 50.512 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 4, PD, n=35,31,35, | 33334.70 picogram (PG)/ML | Standard Deviation 8458.286 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 5, PD, n=38,29,38,46 | 829.03 picogram (PG)/ML | Standard Deviation 374.933 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 21 D post M3, n=23,15, 18,22 | 674.38 picogram (PG)/ML | Standard Deviation 270.355 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 14 D post M3, n=9,9,6,14 | 444.97 picogram (PG)/ML | Standard Deviation 149.504 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 21 D post M3, n=18,15,16,20 | 43914.27 picogram (PG)/ML | Standard Deviation 11231.62 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 3 H post, n=38,29,36,43 | 93.08 picogram (PG)/ML | Standard Deviation 227.209 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 14 D post M3, n=9,11,4,14 | 41809.21 picogram (PG)/ML | Standard Deviation 12065.52 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 9, PD, n=38,28,34,42 | 710.63 picogram (PG)/ML | Standard Deviation 313.891 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 6, 1 H post, n=29,30,36,32 | 1613.65 picogram (PG)/ML | Standard Deviation 493.896 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 3 H post, n=36,30,31,43 | 93.26 picogram (PG)/ML | Standard Deviation 209.024 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 21 D post M3, n=18,14, 18,19 | 2096.98 picogram (PG)/ML | Standard Deviation 769.107 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 3H post, n=37,38,32,43 | 38141.47 picogram (PG)/ML | Standard Deviation 9668.57 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 3 H post, n=37,31,31,37 | 56.04 picogram (PG)/ML | Standard Deviation 48.351 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 1 H post, n=37,28,34,41 | 51.96 picogram (PG)/ML | Standard Deviation 33.876 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 4, PD, n=39,32,39,44 | 811.97 picogram (PG)/ML | Standard Deviation 300.797 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 6, PD, n=36,31,35,45 | 796.74 picogram (PG)/ML | Standard Deviation 321.794 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 7 D post M3, n=7,11,11,8 | 49791.95 picogram (PG)/ML | Standard Deviation 16363.48 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 3 H post, n=35,32,33,30 | 1744.84 picogram (PG)/ML | Standard Deviation 768.485 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 4, 1 H post, n=32,31,33,41 | 34964.84 picogram (PG)/ML | Standard Deviation 10002.35 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 3, 1H post, n=39,38,33,43 | 34207.81 picogram (PG)/ML | Standard Deviation 11060.95 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 12, 1 H post, n=37,30,34,38 | 55.36 picogram (PG)/ML | Standard Deviation 46.136 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 6, PD, n=34,29,35,45 | 32538.92 picogram (PG)/ML | Standard Deviation 8469.383 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 3, PD, n=39,38,37,45 | 33131.16 picogram (PG)/ML | Standard Deviation 11098.58 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 1 H post, n=37,29,36,40 | 35273.76 picogram (PG)/ML | Standard Deviation 11497.23 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 6, 1 H post, n=35,30,32,43 | 60.33 picogram (PG)/ML | Standard Deviation 45.976 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 Baseline, n=43,37,45,38 | 579.25 picogram (PG)/ML | Standard Deviation 277.483 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 1 H post, n=38,30,37,42 | 57.27 picogram (PG)/ML | Standard Deviation 33.59 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 1 H post, n=11,27,34,36 | 1172.10 picogram (PG)/ML | Standard Deviation 300.788 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 15, PD, n=11,27,30,37 | 1157.26 picogram (PG)/ML | Standard Deviation 347.208 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 3, PD, n=36,38,40, 37 | 1689.03 picogram (PG)/ML | Standard Deviation 652.829 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 14 D post M3, n=8,11,6,9 | 1695.08 picogram (PG)/ML | Standard Deviation 234.094 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 4, PD, n=35,33,39, 29 | 1575.82 picogram (PG)/ML | Standard Deviation 606.059 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 3 H post, n=34,26,32,37 | 38.60 picogram (PG)/ML | Standard Deviation 22.256 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 6, PD, n=27,30,38,33 | 1509.95 picogram (PG)/ML | Standard Deviation 425.854 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 1 H post, n=10,28,29,35 | 1205.27 picogram (PG)/ML | Standard Deviation 389.468 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 3 H post, n=17,24,36,37 | 1691.34 picogram (PG)/ML | Standard Deviation 854.596 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Unscheduled, n=0,0,0,1 | 18312.40 picogram (PG)/ML | — |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 18, 1 H post, n=35,27,33,37 | 42.40 picogram (PG)/ML | Standard Deviation 37.672 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 12, 3 H post, n=35,29,33,37 | 37831.60 picogram (PG)/ML | Standard Deviation 11953.37 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 12, PD, n=38,30,37,41 | 669.94 picogram (PG)/ML | Standard Deviation 417.194 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 15, PD, n=35,26,30,37 | 28887.86 picogram (PG)/ML | Standard Deviation 7891.499 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 12, PD, n=32,22,33,39 | 33105.49 picogram (PG)/ML | Standard Deviation 9358.291 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 3 H post, n= | 37923.17 picogram (PG)/ML | Standard Deviation 13928.32 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 5, 1 H post, n=38,30,37,43 | 52.91 picogram (PG)/ML | Standard Deviation 31.684 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 1 H post, n=30,27,31,37 | 28914.08 picogram (PG)/ML | Standard Deviation 9757.638 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 18, PD, n=35,28,34,38 | 396.39 picogram (PG)/ML | Standard Deviation 324.875 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 15, 3 H post, n=10,26,30,34 | 1257.99 picogram (PG)/ML | Standard Deviation 330.407 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 4, 3 H post, n=38,31,35,41 | 64.05 picogram (PG)/ML | Standard Deviation 36.625 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 15, 3 H post, n=26,25,30,33 | 31653.02 picogram (PG)/ML | Standard Deviation 8909.182 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 12, PD, n=13,27,37,37 | 1221.73 picogram (PG)/ML | Standard Deviation 504.928 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 9, 1 H post, n=33,23,32,40 | 34807.59 picogram (PG)/ML | Standard Deviation 11458.57 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 Baseline, n=45,42,46,48 | 709.04 picogram (PG)/ML | Standard Deviation 205.697 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 18, PD, n=27,27,34,38 | 28107.98 picogram (PG)/ML | Standard Deviation 9780.376 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 18, PD, n=8,29,29,36 | 1087.18 picogram (PG)/ML | Standard Deviation 270.541 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 5, 1 H post, n=33,32,40,32 | 1572.92 picogram (PG)/ML | Standard Deviation 565.403 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 1 H post, n=28,27,33,37 | 29913.96 picogram (PG)/ML | Standard Deviation 10878.95 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 9, 1 H post, n=18,27,35,38 | 1591.82 picogram (PG)/ML | Standard Deviation 749.909 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 9, PD, n=33,22,33,42 | 33653.88 picogram (PG)/ML | Standard Deviation 12115.89 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22 month 3, PD, n=41,39,39, 46 | 756.85 picogram (PG)/ML | Standard Deviation 367.05 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 18, 3 H post, n=28,27,32,36 | 31441.25 picogram (PG)/ML | Standard Deviation 10084.47 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 4, 1 H post, n=33,33,36,30 | 1821.73 picogram (PG)/ML | Standard Deviation 817.436 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 3 H post, n=32,29,32,42 | 37139.56 picogram (PG)/ML | Standard Deviation 12656.18 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 3 H post, n=36,27,29,36 | 54.85 picogram (PG)/ML | Standard Deviation 76.984 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 Baseline, n=38,39,41,20 | 384.28 picogram (PG)/ML | Standard Deviation 760.175 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 12, 1 H post, n=14,26,33,34 | 1324.37 picogram (PG)/ML | Standard Deviation 598.12 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 6, 1 H post, n=33,28,33,43 | 34146.93 picogram (PG)/ML | Standard Deviation 10421.73 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 18, 3 H post, n=10,28,27,35 | 1254.63 picogram (PG)/ML | Standard Deviation 304.826 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 9, PD, n=19,27,37,38 | 1519.98 picogram (PG)/ML | Standard Deviation 842.69 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 9, 3 H post, n=37,26,34,40 | 54.65 picogram (PG)/ML | Standard Deviation 36.712 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 1H post, n= 35,38,37,37 | 1778.93 picogram (PG)/ML | Standard Deviation 644.677 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 3 H post, n=36,28,34,40 | 34169.47 picogram (PG)/ML | Standard Deviation 8984.387 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34, month 5, 1 H post, n=34,28,35,42 | 33182.12 picogram (PG)/ML | Standard Deviation 9115.903 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 15, 1 H post, n=38,28,32,38 | 52.10 picogram (PG)/ML | Standard Deviation 89.673 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 3H post, n=36,38,38,35 | 1959.40 picogram (PG)/ML | Standard Deviation 707.293 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42 month 5, PD, n=33,32,39,34 | 1450.71 picogram (PG)/ML | Standard Deviation 599.032 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab 18-34 month 5, PD, n=33,28,35, 46 | 32652.34 picogram (PG)/ML | Standard Deviation 9462.231 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab1-22, month 3, 7 D post M3, n=9,12,14,9 | 274.57 picogram (PG)/ML | Standard Deviation 190.397 |
| GSK933776 (15 mg/kg) | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Ab42, month 3, 7 D post M3, n=9,11,15,6 | 2007.92 picogram (PG)/ML | Standard Deviation 673.666 |
Secondary
Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling
Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.
Time frame: Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK933776 (3 mg/kg) | Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | 5618.72 mL |
| GSK933776 (6 mg/kg) | Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | 5825.03 mL |
| GSK933776 (15 mg/kg) | Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | 5959.42 mL |