Herpes Zoster
Conditions
Keywords
GSK Biologicals, Herpes Zoster (HZ), Vaccine, Varicella Zoster Virus (VZV), Shingles
Brief summary
Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period. No new subjects will be enrolled during the extension phases of the study.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALHerpes Zoster vaccine GSK1437173A Low Dose
Single or two-dose intramuscular injection.
BIOLOGICALHerpes Zoster vaccine GSK1437173A Medium Dose
Single or two-dose intramuscular injection.
BIOLOGICALHerpes Zoster vaccine GSK1437173A High Dose
Single or two-dose intramuscular injection.
BIOLOGICALHerpes Zoster vaccine GSK1437173A Modified
Single or two-dose intramuscular injection.
BIOLOGICALPlacebo
Single intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female aged 60 years or older at the time of the first vaccination. * Written informed consent obtained from the subject
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed. * Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection. * Previous vaccination against HZ. * History of herpes zoster (Shingles). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute disease at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period. * History of or current drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | One month after the second vaccination (Month 3) | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥). |
| Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | One month after the second vaccination (Month 3) | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level. |
| Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | One month after the second vaccination (Month 3) | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Anti-gE Specific Antibody Concentrations | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA. |
| Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | At Months 12, 24 and 36 | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. |
| Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | At Months 12, 24 and 36 | Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. |
| Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old. |
| Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | At Month 12, 24 and 36 | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. |
| Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | At Month 12, 24 and 36 | Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. |
| Frequency of VZV-specific Memory B-cells in a Subset of Subjects | At pre-vaccination (Day 0) and at Month 3 | Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older. |
| Number of Subjects With Different Biochemical and Haematological Levels | At Day 0, Month 2 and Month 3 | Among biochemical and haematological parameters assessed were albumin \[ALB\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], calcium \[CAL\], eosinophils \[EOS\], fibrinogen \[FIB\], haematocrit \[HEM\], hemoglobin \[Hgb\], leucocytes \[LEU\], lymphocytes \[LYM\], lactate dehydrogenate \[LDH\], monocytes \[MON\], neutrophils \[NEU\], partial thromboplastin time \[PTPT\], platelets \[PLA\], pro thrombin time \[PTT\], red blood cells \[RBC\], serum creatinine \[SCREA\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above. |
| Number of German Subjects With Different Biochemical and Haematological Levels | At one week post-vaccination 1 (Month 0) | Among biochemical and haematological parameters assessed were albumin \[ALB\], calcium \[CAL\], fibrinogen \[FIB\], lactate dehydrogenase \[LDH\], partial thrombo-plastin time \[PTPT\], pro thrombin time \[PTT\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | From Month 0 to Month 3 | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | From Month 3 up to Month 36 | Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 3 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | At Months 12, 24 and 36 | Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study. |
| Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
| Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3) | Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). |
Countries
Czechia, Germany, Netherlands, Sweden
Participant flow
Pre-assignment details
Out of 715 subjects enrolled, only 714 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A _LD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm. | 164 |
| GSK1437173A _MD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 166 |
| GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 165 |
| Placebo + GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 165 |
| GSK1437173A_MODIFIED GROUP Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm. | 54 |
| Total | 714 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Months 0-3 | Adverse Event | 0 | 1 | 1 | 0 | 0 |
| Months 0-3 | Lost to Follow-up | 0 | 0 | 0 | 0 | 2 |
| Months 0-3 | Protocol Violation | 1 | 0 | 1 | 0 | 0 |
| Months 0-3 | Serious Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Months 0-3 | Withdrawal by Subject | 2 | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A _LD Group | GSK1437173A _MD Group | GSK1437173A _HD Group | Placebo + GSK1437173A _HD Group | GSK1437173A_MODIFIED GROUP | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 72.8 Years STANDARD_DEVIATION 5.5 | 72.9 Years STANDARD_DEVIATION 5.1 | 73.0 Years STANDARD_DEVIATION 5.7 | 73.1 Years STANDARD_DEVIATION 5.9 | 72.1 Years STANDARD_DEVIATION 5.2 | 72.9 Years STANDARD_DEVIATION 5.5 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage/African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African Heritage | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 162 Participants | 163 Participants | 164 Participants | 165 Participants | 54 Participants | 708 Participants |
| Sex: Female, Male Female | 88 Participants | 100 Participants | 85 Participants | 95 Participants | 36 Participants | 404 Participants |
| Sex: Female, Male Male | 76 Participants | 66 Participants | 80 Participants | 70 Participants | 18 Participants | 310 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 164 | 3 / 166 | 3 / 165 | 5 / 165 | 1 / 54 |
| other Total, other adverse events | 134 / 164 | 142 / 166 | 140 / 165 | 124 / 165 | 19 / 54 |
| serious Total, serious adverse events | 53 / 164 | 57 / 166 | 68 / 165 | 67 / 165 | 22 / 54 |
Outcome results
Primary
Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.
Time frame: One month after the second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A _LD Group | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 12.83 Fold Change | Standard Deviation 13.13 |
| GSK1437173A _MD Group | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 15.00 Fold Change | Standard Deviation 15.86 |
| GSK1437173A _HD Group | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 21.53 Fold Change | Standard Deviation 71.96 |
| Placebo + GSK1437173A _HD Group | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 5.92 Fold Change | Standard Deviation 9.56 |
| GSK1437173A_MODIFIED Group | Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 4.05 Fold Change | Standard Deviation 3.2 |
Primary
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old.
Time frame: One month after the second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 2269.84 T-cells/million cells | Standard Deviation 1934.55 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 2441.95 T-cells/million cells | Standard Deviation 2055.11 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 2449.90 T-cells/million cells | Standard Deviation 1808 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 681.73 T-cells/million cells | Standard Deviation 665.17 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | 512.55 T-cells/million cells | Standard Deviation 463.35 |
Primary
Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥).
Time frame: One month after the second vaccination (Month 3)
Population: The analysis was performed on the According-to-Protocol(ATP) cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK1437173A _LD Group | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | 1801.23 T-cells/million cells |
| GSK1437173A _MD Group | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | 1722.83 T-cells/million cells |
| GSK1437173A _HD Group | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | 1778.48 T-cells/million cells |
| Placebo + GSK1437173A _HD Group | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | 491.03 T-cells/million cells |
| GSK1437173A_MODIFIED Group | Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers | 388.49 T-cells/million cells |
Secondary
Anti-gE Specific Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Months 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 24 | 2363.8 EL.U/mL |
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 12 | 3384.8 EL.U/mL |
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 36 | 2064.1 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 12 | 4280.3 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 36 | 2444.3 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 24 | 2784.6 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 12 | 5258.2 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 24 | 3390.0 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 36 | 2956.4 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 36 | 959.5 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 12 | 1664.5 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 24 | 1126.3 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 24 | 1339.1 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 12 | 1888.2 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 36 | 973.9 EL.U/mL |
Secondary
Anti-gE Specific Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 2 | 3667.6 EL.U/mL |
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Day 0 | 351.6 EL.U/mL |
| GSK1437173A _LD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 3 | 9315.3 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Day 0 | 312.8 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 3 | 12898.0 EL.U/mL |
| GSK1437173A _MD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 2 | 4139.4 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Day 0 | 416.1 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 2 | 5485.6 EL.U/mL |
| GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 3 | 15626.5 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 3 | 6287.2 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Day 0 | 337.2 EL.U/mL |
| Placebo + GSK1437173A _HD Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 2 | 361.5 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 2 | 2148.9 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Day 0 | 323.7 EL.U/mL |
| GSK1437173A_MODIFIED Group | Anti-gE Specific Antibody Concentrations | Anti-gE, Month 3 | 4298.3 EL.U/mL |
Secondary
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 3 | 8821.6 mIU/mL |
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 2 | 4408.1 mIU/mL |
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Day 0 | 1334.9 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 2 | 5131.9 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Day 0 | 1212.0 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 3 | 11451.0 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 3 | 14143.5 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Day 0 | 1510.7 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 2 | 6511.7 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 3 | 6432.2 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Day 0 | 1356.3 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 2 | 1341.6 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Day 0 | 1422.5 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 2 | 3481.2 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 3 | 5357.6 mIU/mL |
Secondary
Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Months 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 36 | 2426.6 mIU/mL |
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 24 | 2557.4 mIU/mL |
| GSK1437173A _LD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 12 | 4190.1 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 24 | 2673.6 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 36 | 2555.0 mIU/mL |
| GSK1437173A _MD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 12 | 4761.3 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 12 | 5559.1 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 24 | 2976.0 mIU/mL |
| GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 36 | 2826.7 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 24 | 1849.3 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 12 | 2704.1 mIU/mL |
| Placebo + GSK1437173A _HD Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 36 | 1729.9 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 36 | 1739.9 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 24 | 1922.6 mIU/mL |
| GSK1437173A_MODIFIED Group | Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations | Anti-VZV, Month 12 | 2733.8 mIU/mL |
Secondary
Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time frame: At Months 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 12 | 1135.8 T-cells/million cells | Standard Deviation 936 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 36 | 827.3 T-cells/million cells | Standard Deviation 922.9 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 24 | 1004.1 T-cells/million cells | Standard Deviation 838.8 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 24 | 1195.5 T-cells/million cells | Standard Deviation 1375.5 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 12 | 1275.5 T-cells/million cells | Standard Deviation 1195.4 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 36 | 969.7 T-cells/million cells | Standard Deviation 1034.9 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 24 | 1079.9 T-cells/million cells | Standard Deviation 948 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 12 | 1274.0 T-cells/million cells | Standard Deviation 995 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 36 | 896.3 T-cells/million cells | Standard Deviation 770.4 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 12 | 340.4 T-cells/million cells | Standard Deviation 296.8 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 36 | 239.7 T-cells/million cells | Standard Deviation 181.7 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 24 | 244.1 T-cells/million cells | Standard Deviation 233.2 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 24 | 285.2 T-cells/million cells | Standard Deviation 255.6 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 12 | 274.5 T-cells/million cells | Standard Deviation 217.3 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 36 | 229.7 T-cells/million cells | Standard Deviation 217.1 |
Secondary
Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time frame: At Month 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 12 | 969.0 T-cells/million cells | Standard Deviation 811.8 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 36 | 753.0 T-cells/million cells | Standard Deviation 852.9 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 24 | 935.2 T-cells/million cells | Standard Deviation 801.5 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 24 | 1079.9 T-cells/million cells | Standard Deviation 1040.1 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 12 | 1057.2 T-cells/million cells | Standard Deviation 943.4 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 36 | 912.9 T-cells/million cells | Standard Deviation 1009.2 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 24 | 981.6 T-cells/million cells | Standard Deviation 890.9 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 12 | 1062.8 T-cells/million cells | Standard Deviation 850.3 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 36 | 823.0 T-cells/million cells | Standard Deviation 727.9 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 12 | 267.5 T-cells/million cells | Standard Deviation 246 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 36 | 202.5 T-cells/million cells | Standard Deviation 166.3 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 24 | 210.8 T-cells/million cells | Standard Deviation 187.2 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 24 | 270.3 T-cells/million cells | Standard Deviation 248.6 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 12 | 221.0 T-cells/million cells | Standard Deviation 180.9 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 36 | 202.8 T-cells/million cells | Standard Deviation 187.1 |
Secondary
Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time frame: At Months 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 36 | 491.8 T-cells/million cells | Standard Deviation 604.1 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 24 | 541.9 T-cells/million cells | Standard Deviation 503.1 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 12 | 659.9 T-cells/million cells | Standard Deviation 594.3 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 24 | 668.9 T-cells/million cells | Standard Deviation 1140.6 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 36 | 583.3 T-cells/million cells | Standard Deviation 819 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 12 | 767.8 T-cells/million cells | Standard Deviation 895.1 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 12 | 718.9 T-cells/million cells | Standard Deviation 634.2 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 24 | 543.6 T-cells/million cells | Standard Deviation 554.7 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 36 | 492.3 T-cells/million cells | Standard Deviation 437 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 24 | 157.0 T-cells/million cells | Standard Deviation 183.4 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 12 | 235.5 T-cells/million cells | Standard Deviation 244.7 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 36 | 172.2 T-cells/million cells | Standard Deviation 155.1 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 36 | 162.0 T-cells/million cells | Standard Deviation 151.4 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 24 | 181.2 T-cells/million cells | Standard Deviation 158.4 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 12 | 176.8 T-cells/million cells | Standard Deviation 152.7 |
Secondary
Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker
Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time frame: At Months 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 24 | 943.0 T-cells/million cells | Standard Deviation 809.5 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 12 | 1056.2 T-cells/million cells | Standard Deviation 901 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 36 | 768.9 T-cells/million cells | Standard Deviation 871.5 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 12 | 1164.7 T-cells/million cells | Standard Deviation 1029.1 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 24 | 1100.2 T-cells/million cells | Standard Deviation 1158.9 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 36 | 890.2 T-cells/million cells | Standard Deviation 883.3 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 24 | 1007.8 T-cells/million cells | Standard Deviation 909.5 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 12 | 1168.3 T-cells/million cells | Standard Deviation 935.4 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 36 | 834.7 T-cells/million cells | Standard Deviation 743.9 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 12 | 291.7 T-cells/million cells | Standard Deviation 266.6 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 36 | 205.8 T-cells/million cells | Standard Deviation 154.5 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 24 | 213.0 T-cells/million cells | Standard Deviation 207.4 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 12 | 243.9 T-cells/million cells | Standard Deviation 204.8 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 36 | 213.9 T-cells/million cells | Standard Deviation 202.2 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 24 | 233.0 T-cells/million cells | Standard Deviation 244.5 |
Secondary
Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time frame: At Month 12, 24 and 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 12 | 673.7 T-cells/million cells | Standard Deviation 616 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 36 | 497.4 T-cells/million cells | Standard Deviation 652.5 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 24 | 567.9 T-cells/million cells | Standard Deviation 527.7 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 24 | 663.1 T-cells/million cells | Standard Deviation 1097 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 12 | 736.2 T-cells/million cells | Standard Deviation 878.5 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 36 | 567.9 T-cells/million cells | Standard Deviation 808.4 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 24 | 591.5 T-cells/million cells | Standard Deviation 586.6 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 12 | 736.7 T-cells/million cells | Standard Deviation 660.7 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 36 | 510.7 T-cells/million cells | Standard Deviation 522.1 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 12 | 193.2 T-cells/million cells | Standard Deviation 239.4 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 36 | 117.9 T-cells/million cells | Standard Deviation 151.7 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 24 | 144.1 T-cells/million cells | Standard Deviation 196.1 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 24 | 133.0 T-cells/million cells | Standard Deviation 158.1 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 12 | 136.0 T-cells/million cells | Standard Deviation 132.8 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker | Month 36 | 98.1 T-cells/million cells | Standard Deviation 116 |
Secondary
Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old.
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Day 0 | 194.47 T-cells/million cells | Standard Deviation 214.96 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Double, Month 3 | 2246.29 T-cells/million cells | Standard Deviation 1976.42 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 2 | 459.01 T-cells/million cells | Standard Deviation 401.25 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 2 | 482.84 T-cells/million cells | Standard Deviation 425.73 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Day 0 | 225.47 T-cells/million cells | Standard Deviation 370.67 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Double, Month 3 | 2372.07 T-cells/million cells | Standard Deviation 1877.43 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 2 | 489.45 T-cells/million cells | Standard Deviation 423.52 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Day 0 | 201.17 T-cells/million cells | Standard Deviation 230.96 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Double, Month 3 | 2569.29 T-cells/million cells | Standard Deviation 2052.74 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Day 0 | 203.70 T-cells/million cells | Standard Deviation 221.97 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Double, Month 3 | 670.80 T-cells/million cells | Standard Deviation 606.93 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 2 | 173.91 T-cells/million cells | Standard Deviation 181.86 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Month 2 | 230.28 T-cells/million cells | Standard Deviation 250.7 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Doubles, Day 0 | 145.95 T-cells/million cells | Standard Deviation 164.57 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers | CD4-All Double, Month 3 | 550.11 T-cells/million cells | Standard Deviation 448.15 |
Secondary
Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 142.88 T-cells/million cells | Standard Deviation 169.52 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 2014.37 T-cells/million cells | Standard Deviation 1849.25 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 385.34 T-cells/million cells | Standard Deviation 348.25 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 405.95 T-cells/million cells | Standard Deviation 359.46 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 153.80 T-cells/million cells | Standard Deviation 214.95 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 2154.81 T-cells/million cells | Standard Deviation 1799.64 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 417.20 T-cells/million cells | Standard Deviation 361.59 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 151.37 T-cells/million cells | Standard Deviation 160.38 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 2303.13 T-cells/million cells | Standard Deviation 1987.94 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 155.90 T-cells/million cells | Standard Deviation 187.47 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 567.33 T-cells/million cells | Standard Deviation 566.48 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 132.62 T-cells/million cells | Standard Deviation 144.06 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 182.82 T-cells/million cells | Standard Deviation 195.36 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 111.55 T-cells/million cells | Standard Deviation 126.92 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 433.56 T-cells/million cells | Standard Deviation 391.64 |
Secondary
Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 156.54 T-cells/million cells | Standard Deviation 199.12 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 1179.29 T-cells/million cells | Standard Deviation 1021.14 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 279.39 T-cells/million cells | Standard Deviation 343.61 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 279.20 T-cells/million cells | Standard Deviation 336.29 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 169.01 T-cells/million cells | Standard Deviation 326.34 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 1296.04 T-cells/million cells | Standard Deviation 1132.18 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 292.15 T-cells/million cells | Standard Deviation 345.65 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 152.28 T-cells/million cells | Standard Deviation 220.5 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 1417.40 T-cells/million cells | Standard Deviation 1303.6 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 157.13 T-cells/million cells | Standard Deviation 180 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 363.23 T-cells/million cells | Standard Deviation 364.74 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 124.05 T-cells/million cells | Standard Deviation 151.42 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 168.34 T-cells/million cells | Standard Deviation 213.83 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 118.35 T-cells/million cells | Standard Deviation 125.08 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 341.36 T-cells/million cells | Standard Deviation 313.79 |
Secondary
Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker
Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 171.21 T-cells/million cells | Standard Deviation 208.49 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 2077.06 T-cells/million cells | Standard Deviation 1860.4 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 416.12 T-cells/million cells | Standard Deviation 369.85 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 442.17 T-cells/million cells | Standard Deviation 363.1 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 191.28 T-cells/million cells | Standard Deviation 307.4 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 2156.40 T-cells/million cells | Standard Deviation 1697.78 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 438.27 T-cells/million cells | Standard Deviation 378.81 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 180.85 T-cells/million cells | Standard Deviation 193.48 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 2315.84 T-cells/million cells | Standard Deviation 1847.24 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 172.41 T-cells/million cells | Standard Deviation 184.32 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 597.76 T-cells/million cells | Standard Deviation 531.07 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 150.47 T-cells/million cells | Standard Deviation 160.29 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 199.34 T-cells/million cells | Standard Deviation 224.39 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 125.22 T-cells/million cells | Standard Deviation 134.81 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 491.06 T-cells/million cells | Standard Deviation 396.39 |
Secondary
Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 97.28 T-cells//million cells | Standard Deviation 137.06 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 1317.39 T-cells//million cells | Standard Deviation 1304.53 |
| GSK1437173A _LD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 251.94 T-cells//million cells | Standard Deviation 277.71 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 256.15 T-cells//million cells | Standard Deviation 304.91 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 1282.96 T-cells//million cells | Standard Deviation 1183.69 |
| GSK1437173A _MD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 121.05 T-cells//million cells | Standard Deviation 296.79 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 1389.62 T-cells//million cells | Standard Deviation 1231.76 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 116.91 T-cells//million cells | Standard Deviation 173.65 |
| GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 263.39 T-cells//million cells | Standard Deviation 284.96 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 110.66 T-cells//million cells | Standard Deviation 162.02 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 95.84 T-cells//million cells | Standard Deviation 125.15 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 350.23 T-cells//million cells | Standard Deviation 380.6 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 81.40 T-cells//million cells | Standard Deviation 107.44 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 252.86 T-cells//million cells | Standard Deviation 253.55 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 120.73 T-cells//million cells | Standard Deviation 148.24 |
Secondary
Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers
Among the activation markers expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Day 0 | 74.62 T-cells/million cells | Standard Deviation 118.02 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 3 | 96.43 T-cells/million cells | Standard Deviation 155.37 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 2 | 85.29 T-cells/million cells | Standard Deviation 139.32 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 2 | 106.23 T-cells/million cells | Standard Deviation 141.63 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Day 0 | 98.88 T-cells/million cells | Standard Deviation 164.52 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 3 | 88.77 T-cells/million cells | Standard Deviation 140.95 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 2 | 86.35 T-cells/million cells | Standard Deviation 168.1 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Day 0 | 122.37 T-cells/million cells | Standard Deviation 221.2 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 3 | 117.70 T-cells/million cells | Standard Deviation 196.09 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Day 0 | 80.54 T-cells/million cells | Standard Deviation 121.84 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 3 | 112.99 T-cells/million cells | Standard Deviation 165.52 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 2 | 120.06 T-cells/million cells | Standard Deviation 221.2 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 2 | 98.97 T-cells/million cells | Standard Deviation 299.34 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Day 0 | 108.21 T-cells/million cells | Standard Deviation 330.11 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers | CD8-All Doubles, Month 3 | 116.41 T-cells/million cells | Standard Deviation 450.85 |
Secondary
Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 41.35 T-cells/million cells | Standard Deviation 54.48 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 69.50 T-cells/million cells | Standard Deviation 105.36 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 63.87 T-cells/million cells | Standard Deviation 82.02 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 66.76 T-cells/million cells | Standard Deviation 90.29 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 61.30 T-cells/million cells | Standard Deviation 118.43 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 65.34 T-cells/million cells | Standard Deviation 64.17 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 47.20 T-cells/million cells | Standard Deviation 64.54 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 56.85 T-cells/million cells | Standard Deviation 78.31 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 85.57 T-cells/million cells | Standard Deviation 105.34 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 35.96 T-cells/million cells | Standard Deviation 69.51 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 76.19 T-cells/million cells | Standard Deviation 72.44 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 71.20 T-cells/million cells | Standard Deviation 93.18 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 2 | 54.63 T-cells/million cells | Standard Deviation 69.92 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Day 0 | 59.94 T-cells/million cells | Standard Deviation 75.13 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker | Month 3 | 33.12 T-cells/million cells | Standard Deviation 47.32 |
Secondary
Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 60.35 T-cells/million cells | Standard Deviation 97.12 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 88.62 T-cells/million cells | Standard Deviation 136.13 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 65.97 T-cells/million cells | Standard Deviation 111.02 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 106.74 T-cells/million cells | Standard Deviation 133.15 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 75.79 T-cells/million cells | Standard Deviation 114.55 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 76.92 T-cells/million cells | Standard Deviation 123.74 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 72.58 T-cells/million cells | Standard Deviation 92.99 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 106.39 T-cells/million cells | Standard Deviation 199.96 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 95.01 T-cells/million cells | Standard Deviation 138.77 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 70.69 T-cells/million cells | Standard Deviation 121.23 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 96.91 T-cells/million cells | Standard Deviation 161.1 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 106.02 T-cells/million cells | Standard Deviation 184.4 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 2 | 95.05 T-cells/million cells | Standard Deviation 326.45 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Day 0 | 123.99 T-cells/million cells | Standard Deviation 360.75 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker | Month 3 | 125.69 T-cells/million cells | Standard Deviation 480.05 |
Secondary
Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker
Among other activation markers expressed were interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 81.42 T-cells/million cells | Standard Deviation 108.62 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 69.06 T-cells/million cells | Standard Deviation 97.12 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 61.05 T-cells/million cells | Standard Deviation 106.36 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 78.18 T-cells/million cells | Standard Deviation 92.65 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 83.13 T-cells/million cells | Standard Deviation 131.07 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 65.08 T-cells/million cells | Standard Deviation 83.71 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 83.07 T-cells/million cells | Standard Deviation 186.88 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 90.71 T-cells/million cells | Standard Deviation 140.18 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 103.17 T-cells/million cells | Standard Deviation 179.57 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 63.56 T-cells/million cells | Standard Deviation 89.18 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 82.95 T-cells/million cells | Standard Deviation 99.47 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 82.47 T-cells/million cells | Standard Deviation 126.08 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 2 | 68.98 T-cells/million cells | Standard Deviation 85.29 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Day 0 | 43.03 T-cells/million cells | Standard Deviation 58.88 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker | Month 3 | 56.42 T-cells/million cells | Standard Deviation 120.85 |
Secondary
Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker
Among other activation markers expressed were interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or cluster of differentiation 40-ligand \[CD40-L\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time frame: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)
Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 74.94 T-cells/million cells | Standard Deviation 113.07 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 86.81 T-cells/million cells | Standard Deviation 120.39 |
| GSK1437173A _LD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 71.42 T-cells/million cells | Standard Deviation 96.41 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 83.01 T-cells/million cells | Standard Deviation 124.5 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 87.33 T-cells/million cells | Standard Deviation 117.28 |
| GSK1437173A _MD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 76.75 T-cells/million cells | Standard Deviation 137.37 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 75.88 T-cells/million cells | Standard Deviation 129.33 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 111.54 T-cells/million cells | Standard Deviation 204.36 |
| GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 99.07 T-cells/million cells | Standard Deviation 139.42 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 81.54 T-cells/million cells | Standard Deviation 119.17 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 106.97 T-cells/million cells | Standard Deviation 167.59 |
| Placebo + GSK1437173A _HD Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 111.15 T-cells/million cells | Standard Deviation 217.08 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 2 | 115.82 T-cells/million cells | Standard Deviation 356.29 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Day 0 | 122.68 T-cells/million cells | Standard Deviation 362.64 |
| GSK1437173A_MODIFIED Group | Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker | Month 3 | 136.22 T-cells/million cells | Standard Deviation 470.58 |
Secondary
Frequency of VZV-specific Memory B-cells in a Subset of Subjects
Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.
Time frame: At pre-vaccination (Day 0) and at Month 3
Population: The analysis was performed on the Total cohort for persistence at Month 12, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Month 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A _LD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Day 0 | 336.5 B-cells/million cells | Standard Deviation 359.5 |
| GSK1437173A _LD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Month 3 | 5699.3 B-cells/million cells | Standard Deviation 8166.2 |
| GSK1437173A _MD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Day 0 | 490.4 B-cells/million cells | Standard Deviation 704.7 |
| GSK1437173A _MD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Month 3 | 5997.1 B-cells/million cells | Standard Deviation 5034.6 |
| GSK1437173A _HD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Day 0 | 356.6 B-cells/million cells | Standard Deviation 348 |
| GSK1437173A _HD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Month 3 | 9707.5 B-cells/million cells | Standard Deviation 8787.1 |
| Placebo + GSK1437173A _HD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Month 3 | 1583.7 B-cells/million cells | Standard Deviation 2266 |
| Placebo + GSK1437173A _HD Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Day 0 | 332.3 B-cells/million cells | Standard Deviation 404.9 |
| GSK1437173A_MODIFIED Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Day 0 | 380.6 B-cells/million cells | Standard Deviation 299.7 |
| GSK1437173A_MODIFIED Group | Frequency of VZV-specific Memory B-cells in a Subset of Subjects | Memory B-cells, Month 3 | 1042.2 B-cells/million cells | Standard Deviation 1139.9 |
Secondary
Number of German Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were albumin \[ALB\], calcium \[CAL\], fibrinogen \[FIB\], lactate dehydrogenase \[LDH\], partial thrombo-plastin time \[PTPT\], pro thrombin time \[PTT\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.
Time frame: At one week post-vaccination 2 (Month 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 4 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Missing | 5 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Within | 14 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Above | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Missing | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 16 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 6 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Missing | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 4 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Missing | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Missing | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 18 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Missing | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Below | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Above | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 18 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 19 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 5 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 8 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 2 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Within | 4 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 6 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Above | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 22 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 23 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 2 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 24 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 15 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Within | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 23 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 8 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 5 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 10 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Within | 16 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Above | 3 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 5 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 11 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Above | 3 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 19 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 3 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 8 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 8 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Missing | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Above | 3 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Within | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Within | 15 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 20 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 22 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 20 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 6 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Within | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 22 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 11 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Within | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Within | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Above | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 19 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
Secondary
Number of German Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were albumin \[ALB\], calcium \[CAL\], fibrinogen \[FIB\], lactate dehydrogenase \[LDH\], partial thrombo-plastin time \[PTPT\], pro thrombin time \[PTT\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.
Time frame: At one week post-vaccination 1 (Month 0)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 21 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Within | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 22 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 3 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 19 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 22 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Below | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 9 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 8 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Missing | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Missing | Above | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Missing | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Above | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Missing | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 6 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Above | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Within | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 8 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Below | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Missing | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Missing | 1 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Above | 0 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Above | 2 Participants |
| GSK1437173A _LD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Within | 18 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Within | 3 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 7 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 23 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 11 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 24 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 24 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Below | 1 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 8 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Above | 2 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 24 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Within | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Above | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 5 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Within | 19 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Below | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 5 Participants |
| GSK1437173A _MD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 10 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 21 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 8 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 4 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 10 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Within | 19 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Above | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Within | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Above | 3 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 23 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 22 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Below | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Within | 1 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Below | Missing | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 2 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 21 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 22 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 24 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 24 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Within | 22 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Missing | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Within | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Above | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 22 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Within | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Within | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | CAL - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | TP - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Missing | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Below | Within | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTPT - Missing | Missing | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Within | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Within | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | FIB - Above | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | PTT - Missing | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | LDH- Within | Missing | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of German Subjects With Different Biochemical and Haematological Levels | ALB - Within | Below | 2 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 30 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 44 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 51 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 94 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 40 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 68 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 115 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 26 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 99 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 23 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 93 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 21 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 54 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 49 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 33 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 66 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 43 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 122 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 99 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 24 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 99 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 52 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 30 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 68 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 45 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 30 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 27 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 93 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 49 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 48 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 93 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 66 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 41 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 39 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 19 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 30 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 12 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 47 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 23 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 47 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 52 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 59 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 32 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 69 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 39 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 74 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 36 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 18 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 56 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 48 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 19 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 57 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 47 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 18 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 60 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 32 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 80 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 61 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 85 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 41 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 57 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 89 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 48 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 34 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 70 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 59 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 25 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 17 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 52 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 15 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 6 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 48 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 71 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 13 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 39 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 18 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 13 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 46 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 46 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 59 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 41 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 70 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 35 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 20 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 52 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 73 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 42 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 57 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 18 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 51 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 43 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 67 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 24 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 22 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 34 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 59 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 47 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 27 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 46 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 9 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 49 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 11 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 38 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 27 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 21 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 41 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 33 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 9 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 36 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 25 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 20 Participants |
| GSK1437173A _LD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 55 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 22 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 52 Participants |
| GSK1437173A _MD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 54 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 24 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 41 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 13 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 16 Participants |
Secondary
Number of Subjects With Different Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were albumin \[ALB\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], calcium \[CAL\], eosinophils \[EOS\], fibrinogen \[FIB\], haematocrit \[HEM\], hemoglobin \[Hgb\], leucocytes \[LEU\], lymphocytes \[LYM\], lactate dehydrogenate \[LDH\], monocytes \[MON\], neutrophils \[NEU\], partial thromboplastin time \[PTPT\], platelets \[PLA\], pro thrombin time \[PTT\], red blood cells \[RBC\], serum creatinine \[SCREA\], total protein \[TP\]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
Time frame: At Day 0, Month 2 and Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Below | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Within | 151 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Below | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Above | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Below | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Within | 129 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Below | 27 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Within | 145 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Below | 27 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Above | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Unknown | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Above | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Unknown | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Within | 136 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Above | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Within | 145 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Below | 18 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Below | 25 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Above | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Within | 141 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Above | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Below | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Unknown | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Below | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Within | 62 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Above | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Above | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Below | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Within | 147 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Within | 68 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Above | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Below | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Within | 152 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Within | 62 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Below | 23 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Below | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Within | 130 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Within | 132 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Within | 67 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Above | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Below | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Within | 140 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Within | 57 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Within | 144 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Within | 131 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Above | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Above | 11 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Below | 27 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Below | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Below | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Within | 57 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Within | 134 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Below | 26 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Below | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Below | 12 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Within | 61 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Within | 138 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Above | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Below | 23 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Within | 64 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Above | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Above | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Within | 66 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Below | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Within | 152 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Above | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Below | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Above | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Within | 152 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Within | 128 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Above | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Within | 68 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Below | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Within | 153 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Within | 156 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Below | 15 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Within | 63 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Above | 25 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Above | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Above | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Unknown | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Above | 24 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Below | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Below | 30 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Within | 148 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Within | 135 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Above | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Above | 12 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Above | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Above | 29 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Within | 137 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Within | 153 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Above | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Below | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Within | 130 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Within | 148 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Below | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Above | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Above | 10 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Below | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Below | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Below | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Above | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Within | 70 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Above | 30 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Within | 40 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Within | 65 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Below | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Above | 10 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Above | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Above | 2 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Within | 68 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Within | 150 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Above | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Within | 44 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Within | 64 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Unknown | 8 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Above | 32 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Below | 4 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Within | 133 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Above | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Below | 21 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Within | 40 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Within | 153 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Above | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Unknown | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Below | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Within | 137 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Within | 144 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Above | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Within | 149 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Above | 13 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Above | 37 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Within | 146 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Within | 36 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Above | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Above | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Unknown | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Below | 5 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Above | 22 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Within | 42 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Above | 3 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Above | 9 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Within | 127 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Unknown | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Below | 10 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Below | 7 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Below | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Unknown | 1 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Within | 59 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Below | 11 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Above | 6 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Below | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Above | 18 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Above | 17 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Within | 151 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Above | 39 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Within | 144 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Within | 127 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Within | 138 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Below | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Within | 61 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Within | 157 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Within | 76 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Below | 9 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Below | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Above | 41 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Below | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Within | 34 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Unknown | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Above | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Above | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Above | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Above | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Above | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Below | 16 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Within | 75 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Below | 19 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Below | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Above | 13 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Above | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Within | 144 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Within | 152 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Above | 40 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Above | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Above | 15 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Within | 76 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Within | 35 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Below | 9 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Within | 58 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Unknown | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Within | 135 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Within | 155 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Unknown | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Below | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Below | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Above | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Within | 140 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Above | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Above | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Above | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Within | 153 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Within | 62 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Unknown | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Above | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Within | 151 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Within | 151 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Below | 10 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Within | 42 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Above | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Above | 13 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Above | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Below | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Above | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Above | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Above | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Within | 38 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Below | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Above | 9 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Unknown | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Within | 61 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Within | 146 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Below | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Above | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Within | 140 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Within | 75 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Within | 138 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Below | 23 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Below | 22 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Above | 9 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Within | 151 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Within | 138 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Below | 13 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Unknown | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Below | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Above | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Above | 6 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Below | 23 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Above | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Within | 141 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Below | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Within | 68 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Above | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Within | 62 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Within | 143 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Unknown | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Within | 142 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Above | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Above | 31 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Below | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Within | 64 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Above | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Below | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Within | 147 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Within | 36 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Within | 155 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Within | 152 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Below | 14 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Below | 10 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Above | 6 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Within | 154 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Within | 150 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Within | 132 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Below | 8 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Below | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Above | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Within | 150 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Above | 34 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Within | 65 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Above | 9 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Below | 6 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Within | 148 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Within | 75 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Within | 63 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Below | 21 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Below | 7 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Above | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Within | 131 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Within | 127 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Above | 10 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Within | 147 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Below | 5 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Unknown | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Below | 3 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Above | 14 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Within | 149 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Unknown | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Within | 70 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Above | 4 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Above | 11 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Within | 154 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Below | 12 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Within | 142 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Above | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Below | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Below | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Within | 64 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Within | 144 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Within | 141 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Above | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Above | 14 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Above | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Below | 21 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Within | 150 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Below | 18 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Within | 137 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Below | 23 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Unknown | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Below | 14 Participants |
| GSK1437173A _MD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Above | 31 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Within | 142 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Within | 155 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Below | 15 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Above | 18 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Within | 126 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Within | 36 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Below | 19 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Within | 147 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Above | 11 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Below | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Unknown | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Below | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Below | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Within | 145 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Within | 59 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Below | 11 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Unknown | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Within | 66 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Above | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Above | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Within | 58 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Below | 14 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Within | 59 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Above | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Below | 11 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Within | 62 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Above | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Below | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Within | 61 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Above | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Within | 64 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Above | 10 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Above | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Within | 154 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Below | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Within | 156 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Within | 66 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Above | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Unknown | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Below | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Above | 11 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Within | 146 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Above | 13 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Within | 145 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Above | 15 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Within | 147 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Above | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Within | 144 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Below | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Within | 63 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Above | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Within | 129 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Below | 27 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Above | 8 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Within | 128 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Below | 25 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Below | 26 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Within | 131 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Above | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Below | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Within | 128 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Above | 32 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Below | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Above | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Within | 129 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Above | 32 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Below | 25 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Within | 130 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Above | 28 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Below | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Within | 134 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Below | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Within | 65 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Above | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Below | 19 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Below | 26 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Within | 134 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Above | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Below | 26 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Within | 133 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Above | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Within | 153 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Above | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Below | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Within | 153 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Above | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Below | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Within | 149 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Above | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Unknown | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Below | 24 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Within | 130 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Above | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Below | 23 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Within | 131 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Above | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Within | 138 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Above | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Within | 66 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Above | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Above | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Within | 152 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Above | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Within | 151 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Unknown | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Within | 153 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Unknown | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Within | 153 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Below | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Within | 152 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Above | 8 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Within | 147 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Above | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Above | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Within | 68 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Above | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Within | 131 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Above | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Above | 13 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Below | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Above | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Unknown | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Within | 42 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Unknown | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Below | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Within | 57 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Below | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Above | 7 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Below | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Within | 149 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Above | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Within | 145 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Above | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Below | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Within | 72 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Below | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Below | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Within | 70 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Above | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Unknown | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Below | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Within | 135 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Above | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Within | 128 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Unknown | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Below | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Above | 23 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Unknown | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Above | 35 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Unknown | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Below | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Within | 147 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Above | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Unknown | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Within | 37 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Below | 5 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Above | 35 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Within | 42 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Above | 3 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Below | 6 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Within | 61 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Above | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Within | 40 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Unknown | 2 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Above | 32 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Below | 25 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Within | 128 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Below | 27 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Above | 9 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Unknown | 1 Participants |
| GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Below | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Above | 38 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Within | 71 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Within | 44 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Within | 149 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Within | 39 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Within | 154 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Above | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Below | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Above | 35 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Within | 155 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Below | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Within | 65 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Above | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Within | 69 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Within | 153 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Below | 8 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Within | 64 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Above | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Above | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Within | 39 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Within | 154 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Above | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Within | 148 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Within | 151 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Within | 137 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Within | 142 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Above | 9 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Above | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Within | 71 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Within | 136 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Within | 134 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Below | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Above | 22 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Above | 35 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Above | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Within | 35 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Below | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Above | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Above | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Within | 69 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Within | 148 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Above | 8 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Above | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Below | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Unknown | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Below | 23 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Above | 9 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Above | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Below | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Above | 9 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Below | 28 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Within | 135 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Above | 7 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Above | 27 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Above | 11 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Within | 132 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Within | 151 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Below | 15 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Above | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Within | 148 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Unknown | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Within | 147 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Below | 25 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Above | 14 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Within | 68 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Below | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Below | 20 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Within | 148 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Above | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Above | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Within | 132 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Above | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Below | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Below | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Within | 71 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Within | 70 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Above | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Above | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Within | 134 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Below | 22 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Within | 55 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Within | 137 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Below | 17 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Above | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Below | 26 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Within | 55 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Below | 17 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Above | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Within | 142 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Above | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Below | 24 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Within | 61 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Below | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Within | 136 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Below | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Within | 150 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Above | 2 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Within | 72 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Above | 28 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Within | 153 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Within | 134 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Within | 137 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Above | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Above | 30 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Below | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Within | 147 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Above | 11 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Within | 145 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Below | 12 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Within | 150 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Above | 8 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Below | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Within | 150 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Within | 62 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Above | 8 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Below | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Unknown | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Within | 43 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Below | 8 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Below | 17 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Within | 64 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Above | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Above | 10 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Within | 137 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Within | 146 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Below | 24 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Unknown | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Above | 13 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Below | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Within | 70 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Within | 135 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Above | 11 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Within | 148 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Above | 5 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Unknown | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Below | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Below | 23 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Within | 153 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Unknown | 6 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Within | 136 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Above | 4 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Within | 131 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Above | 19 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Within | 145 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Unknown | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Within | 42 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Below | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Below | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Within | 19 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Within | 48 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Within | 49 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Within | 43 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Within | 44 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Above | 11 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Within | 38 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Above | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Below | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Within | 51 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Within | 49 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Below | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Within | 20 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Day 0 | Unknown | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Within | 19 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Within | 42 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Below | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Within | 52 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Within | 42 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Within | 51 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 3 | Above | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Within | 48 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Day 0 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | SCREA, Month 2 | Above | 11 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Within | 48 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Above | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Within | 50 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 2 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Within | 23 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Below | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Day 0 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Within | 44 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Within | 45 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Within | 49 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Within | 21 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Within | 24 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Within | 20 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Above | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Below | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Unknown | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Within | 48 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | MON, Month 3 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Below | 8 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Within | 17 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Within | 18 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Day 0 | Unknown | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Below | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Within | 50 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Day 0 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 3 | Below | 7 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 3 | Below | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Within | 43 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 3 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Within | 16 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Below | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Within | 45 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Below | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Within | 11 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LDH, Day 0 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALB, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Month 2 | Within | 42 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LYM, Day 0 | Unknown | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Below | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Within | 47 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Above | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Within | 20 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 2 | Above | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Above | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Within | 45 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Month 3 | Above | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTPT, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Within | 42 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Within | 10 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 3 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Day 0 | Above | 14 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Within | 50 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Within | 21 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | NEU, Month 2 | Within | 47 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | AST, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Within | 46 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Within | 50 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | LEU, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HgB, Month 2 | Below | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Month 3 | Below | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Within | 12 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Within | 21 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Below | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | HEM, Day 0 | Below | 4 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 2 | Above | 10 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Within | 22 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Within | 11 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Day 0 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Within | 48 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Below | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 2 | Within | 19 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | TP, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PTT, Month 3 | Above | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 2 | Within | 47 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | ALT, Day 0 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Within | 9 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | RBC, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Month 3 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 3 | Below | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Above | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Within | 23 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Day 0 | Above | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Month 2 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Above | 3 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Unknown | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Within | 49 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | FIB, Month 3 | Above | 12 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | CAL, Month 3 | Below | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | PLA, Day 0 | Below | 2 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | BAS, Day 0 | Below | 1 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Different Biochemical and Haematological Levels | EOS, Day 0 | Unknown | 1 Participants |
Secondary
Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes
Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Month 0 to Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes | 0 Participants |
Secondary
Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes
Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Month 3 up to Month 36
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 3 - Month 12 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 24 - Month 36 | 0 Participants |
| GSK1437173A _LD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 12 - Month 24 | 1 Participants |
| GSK1437173A _MD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 12 - Month 24 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 3 - Month 12 | 0 Participants |
| GSK1437173A _MD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 24 - Month 36 | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 12 - Month 24 | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 3 - Month 12 | 0 Participants |
| GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 24 - Month 36 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 3 - Month 12 | 1 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 24 - Month 36 | 0 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 12 - Month 24 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 12 - Month 24 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 3 - Month 12 | 0 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes | Month 24 - Month 36 | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| GSK1437173A _MD Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 3 to Month 12
Population: The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A _LD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 - Month 24 | 21 Participants |
| GSK1437173A _LD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 3 - Month 12 | 11 Participants |
| GSK1437173A _LD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 24 - Month 36 | 19 Participants |
| GSK1437173A _MD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 - Month 24 | 27 Participants |
| GSK1437173A _MD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 3 - Month 12 | 14 Participants |
| GSK1437173A _MD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 24 - Month 36 | 12 Participants |
| GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 - Month 24 | 29 Participants |
| GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 3 - Month 12 | 11 Participants |
| GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 24 - Month 36 | 25 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 3 - Month 12 | 16 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 - Month 24 | 25 Participants |
| Placebo + GSK1437173A _HD Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 24 - Month 36 | 20 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 - Month 24 | 11 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 24 - Month 36 | 5 Participants |
| GSK1437173A_MODIFIED Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 3 - Month 12 | 3 Participants |