Trial Outcomes & Findings for Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma (NCT NCT00896480)
NCT ID: NCT00896480
Last Updated: 2021-04-08
Results Overview
OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic-resonance imaging: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR.
COMPLETED
PHASE2
24 participants
From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions
2021-04-08
Participant Flow
During the screening the following steps occurred: check for inclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK2132231A Group
Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
GSK2132231A Group
Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
|
|---|---|
|
Overall Study
Disease progression/recurrence
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GSK2132231A Group
n=24 Participants
Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
|
|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 12.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesionsPopulation: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment
OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic-resonance imaging: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response PR
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response SD
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response SD/PR
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response PD
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response NE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best objective response Yes
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best response CR
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Best objective response No
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Disease Control Yes
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment
Disease Control No
|
4 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesionsPopulation: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment
Assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs) and non-TLs (NTL) followed up until disease progression. MLs assessed for matching below MR definitions. If evaluability per RECIST: a) MR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). If non-evaluability per RECIST (due to LD\<20mm): a) MR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion).
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response SD/PD
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response PD (SPD/MR)
|
1 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response CR
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response PR
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response MR (SD/PR)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response MR (SD/PD)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response SD
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response PD (SPD)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Mixed Response (MR) to GSK2132231A
Best response NE
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or deathPopulation: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment
TTF was defined as withdrawal from treatment with the GSK2132231A study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=8 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Time to Treatment Failure (TTF), by Gene Signature
|
14.8 Months
Interval 2.3 to
Upper limit not calculated as 1 patient (among 8) still under treatment at the time of the analysis.
|
2.3 Months
Interval 0.5 to 15.0
|
2.4 Months
Interval 0.5 to 4.6
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose anti-MAGE-A3 antibody concentration was greater than or equal to 27 EL.U/mL. D=Day W=Week
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=7 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=5 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=6 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W32
|
6128.0 EL.U/mL
Interval 3601.6 to 10426.5
|
8384.1 EL.U/mL
Interval 459.4 to 153006.6
|
9641.0 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, PRE
|
13.9 EL.U/mL
Interval 6.2 to 31.4
|
15.3 EL.U/mL
Interval 4.7 to 49.9
|
13.8 EL.U/mL
Interval 6.1 to 31.3
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, D2
|
13.9 EL.U/mL
Interval 6.2 to 30.8
|
16.8 EL.U/mL
Interval 3.2 to 86.8
|
14.2 EL.U/mL
Interval 5.8 to 34.7
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, D7
|
16.1 EL.U/mL
Interval 6.9 to 37.4
|
18.7 EL.U/mL
Interval 5.9 to 59.2
|
15.5 EL.U/mL
Interval 7.3 to 32.7
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, D15
|
48.5 EL.U/mL
Interval 11.6 to 202.6
|
72 EL.U/mL
Interval 7.4 to 699.2
|
55.1 EL.U/mL
Interval 5.9 to 512.2
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, D16
|
55.4 EL.U/mL
Interval 11.8 to 260.6
|
102.4 EL.U/mL
Interval 0.7 to 15279.4
|
62.2 EL.U/mL
Interval 5.8 to 662.9
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W5
|
1396.9 EL.U/mL
Interval 234.5 to 8321.5
|
4120.2 EL.U/mL
Interval 2093.0 to 8111.0
|
1484.1 EL.U/mL
Interval 736.8 to 2989.6
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W11
|
4161.6 EL.U/mL
Interval 1542.3 to 11229.3
|
9775.9 EL.U/mL
Interval 3065.3 to 31177.1
|
6181.6 EL.U/mL
Interval 3414.2 to 11191.8
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W13
|
7797.4 EL.U/mL
Interval 4564.5 to 13320.2
|
13789.3 EL.U/mL
Interval 7278.1 to 26125.3
|
8046.1 EL.U/mL
Interval 7249.1 to 8930.8
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W21
|
7400.3 EL.U/mL
Interval 4304.0 to 12724.1
|
12544.5 EL.U/mL
Interval 371.2 to 423881.3
|
10790.0 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W54
|
6542.6 EL.U/mL
Interval 4660.3 to 9185.1
|
12357 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W76
|
3539.3 EL.U/mL
Interval 2578.1 to 4859.0
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W78
|
3869.0 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
9219 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W100
|
4260.0 EL.U/mL
Interval 452.7 to 40086.0
|
9230 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W102
|
4804.1 EL.U/mL
Interval 1467.6 to 15725.7
|
12030 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W124
|
1575.0 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
7466 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W126
|
3699.8 EL.U/mL
Interval 2894.3 to 4729.5
|
11889 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W148
|
1754.4 EL.U/mL
Interval 351.7 to 8751.9
|
8865 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W150
|
3077.8 EL.U/mL
Interval 5.3 to 1801276.0
|
10663.0 EL.U/mL
Range not available, as there was only one subject included in the analysis at this timepoint.
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, W174
|
2248.7 EL.U/mL
Interval 226.4 to 22332.9
|
—
|
—
|
|
Anti-MAGE-A3 Antibody Concentrations
Anti-MAGE-A3, CCL
|
4057.1 EL.U/mL
Interval 0.1 to 135760000.0
|
—
|
10004.8 EL.U/mL
Interval 4092.9 to 24455.9
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=7 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=5 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=6 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, D7
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, D15
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W21
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W100
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W126
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, PRE
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, D2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, D16
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W5
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W11
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W13
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W32
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W54
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W76
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W78
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W102
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W124
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W148
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W150
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, W174
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Patients for Anti-MAGE-A3
Anti-MAGE-A3, CCL
|
2 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 2 to Concluding visit (CCL:at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=7 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
n=5 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
n=6 Participants
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W11
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W174
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, CCL
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, D2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, D7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, D15
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, D16
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W5
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W13
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W21
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W32
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W54
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W76
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W78
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W100
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W102
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W124
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W126
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W148
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies
Anti-MAGE-A3, W150
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
This endpoint presents the geometric mean concentration, expressed in titers, of anti-MAGE-A3 specific CD4+ and CD8+ T-cells. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=18 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) PRE
|
1.05 Titers
Interval 0.98 to 1.11
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) PRE
|
1.01 Titers
Interval 0.99 to 1.03
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W5
|
3.36 Titers
Interval 2.2 to 5.13
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W5
|
1 Titers
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W13
|
5.35 Titers
Interval 2.42 to 11.79
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W13
|
1 Titers
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W32
|
5.29 Titers
Interval 2.09 to 13.37
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W32
|
1.04 Titers
Interval 0.99 to 1.09
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W54
|
2.83 Titers
Interval 1.04 to 7.68
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W54
|
1 Titers
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W78
|
2.62 Titers
Interval 0.07 to 92.58
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W78
|
1 Titers
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) W102
|
2.13 Titers
Interval 0.29 to 15.91
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) W102
|
1.05 Titers
Interval 0.86 to 1.28
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD4.TNFα (+) + IFNγ (+) CCL
|
2.42 Titers
Interval 0.0 to 185163.6
|
—
|
—
|
|
Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization
CD8.TNFα (+) + IFNγ (+) CCL
|
1 Titers
Interval 1.0 to 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=18 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) PRE
|
1 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) PRE
|
1 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W5
|
15 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W5
|
0 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W13
|
11 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W13
|
0 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W32
|
9 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W32
|
2 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W54
|
4 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W54
|
0 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W78
|
2 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W78
|
0 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) W102
|
2 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) W102
|
1 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) CCL
|
1 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) CCL
|
0 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD4.TNFα (+) + IFNγ (+) At any time point
|
15 Participants
|
—
|
—
|
|
Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off
CD8.TNFα (+) + IFNγ (+) At any time point
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Week 5 to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)Population: The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.
A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=17 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W5
|
5 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W5
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W13
|
8 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W13
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W32
|
4 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W32
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W54
|
2 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W54
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W78
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W78
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) W102
|
1 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) W102
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) CCL
|
1 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) CCL
|
0 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD4.TNFα (+) + IFNγ (+) At any time point
|
12 Participants
|
—
|
—
|
|
Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)
CD8.TNFα (+) + IFNγ (+) At any time point
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Days 0-30) post-administration periodsPopulation: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient's previous therapeutic regimen).
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0.
Any event, Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0.
Any event, Grade 4
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 to CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completionPopulation: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A ASCI study treatment.
Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients Reported With Serious Adverse Events (SAEs)
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. ALT - SCR G0; SE G3 = ALT with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G0
|
20 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G3
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. AST - SCR G0; SE G3 = AST with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G0
|
19 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G1
|
5 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. ALK - SCR G0; SE G3 = ALK with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR UNK; SE UNK
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G0
|
17 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G1
|
6 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade
ALK - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. BIL - SCR G0; SE G3 = BIL with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G0
|
24 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade
BIL - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. CREA - SCR G0; SE G3 = CREA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G0
|
20 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G2
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. GGT - SCR G0; SE G3 = GGT with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE G1
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE G0
|
17 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE G3
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade
GGT - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. HGB - SCR G0; SE G3 = HGB with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G0
|
14 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G1
|
9 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G1
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. HCA - SCR G0; SE G3 = HCA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE G0
|
15 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE G0
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE G0
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade
HCA - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. HKA - SCR G0; SE G3 = HKA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE G0
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE G0
|
17 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE G2
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade
HKA - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. HNA - SCR G0; SE G3 = HNA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE G0
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE G0
|
19 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade
HNA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. hAL - SCR G0; SE G3 = hAL with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE G0
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE G1
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE G0
|
21 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade
hAL - SCR G0; SE UNK
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. hCA - SCR G0; SE G3 = hCA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE G0
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE G0
|
18 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE G0
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE G1
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade
hCA - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. hKA - SCR G0; SE G3 = hKA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE G0
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE G0
|
19 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade
hKA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. hNA - SCR G0; SE G3 = hNA with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE G0
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR UNK; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE G0
|
18 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE G1
|
4 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade
hNA - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. LEU - SCR G0; SE G3 = LEU with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G0
|
21 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G0
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. LYM - SCR G0; SE G3 = LYM with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G0
|
17 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G2
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G0
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G1
|
3 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade
LYM - SCR G1; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. NEU - SCR G0; SE G3 = NEU with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G0
|
21 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G1
|
2 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G2
|
1 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). \[e.g. PLT - SCR G0; SE G3 = PLT with no abnormality/normal value at screening and with Severe abnormality at study end\].
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G0
|
24 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G1
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G2
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G3
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE G4
|
0 Participants
|
—
|
—
|
|
Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade
PLT - SCR G0; SE UNK
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Day 0-30) follow-up period post treatment administration.Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with any AEs
|
24 Participants
|
—
|
—
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with G1 AEs
|
6 Participants
|
—
|
—
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with G2 AEs
|
15 Participants
|
—
|
—
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with G3 AEs
|
3 Participants
|
—
|
—
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with G4 AEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade
Patients with G5 AEs
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Day 0-30) follow-up period post treatment administration.Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with any related AEs
|
23 Participants
|
—
|
—
|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with G1 related AEs
|
11 Participants
|
—
|
—
|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with G2 related AEs
|
12 Participants
|
—
|
—
|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with G3 related AEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with G4 related AEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration
Patients with G5 related AEs
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Day 0-30) follow-up period post treatment administration.Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with G1 SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with any SAEs
|
2 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with G2 SAEs
|
1 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with G3 SAEs
|
1 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with G4 SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade
Patients with G5 SAEs
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within the 31-day (Day 0-30) follow-up period post treatment administration.Population: The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.
SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.
Outcome measures
| Measure |
GSK2132231A GS+/+ Group
n=24 Participants
Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening.
|
GSK2132231A GS+/- Group
Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening.
|
GSK2132231A GS- Group
Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening.
|
|---|---|---|---|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with any related SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with G1 related SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with G2 related SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with G3 related SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with G4 related SAEs
|
0 Participants
|
—
|
—
|
|
Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration
Patients with G5 related SAEs
|
0 Participants
|
—
|
—
|
Adverse Events
GSK2132231A Group
Serious adverse events
| Measure |
GSK2132231A Group
n=24 participants at risk
Patients planned to receive intramuscularly up to 24 doses of GSK2132231A (the study product), in 4 cycles.
|
|---|---|
|
Cardiac disorders
Cardiac disorder
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
4.2%
1/24 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
Other adverse events
| Measure |
GSK2132231A Group
n=24 participants at risk
Patients planned to receive intramuscularly up to 24 doses of GSK2132231A (the study product), in 4 cycles.
|
|---|---|
|
General disorders
Administration site pain
|
8.3%
2/24 • Number of events 4 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • Number of events 3 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Asthenia
|
37.5%
9/24 • Number of events 19 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Chills
|
16.7%
4/24 • Number of events 8 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • Number of events 3 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Discomfort
|
12.5%
3/24 • Number of events 10 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Fatigue
|
29.2%
7/24 • Number of events 13 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Nervous system disorders
Headache
|
29.2%
7/24 • Number of events 31 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Influenza like illness
|
29.2%
7/24 • Number of events 40 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Injection site erythema
|
16.7%
4/24 • Number of events 7 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Injection site induration
|
8.3%
2/24 • Number of events 7 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Injection site pain
|
50.0%
12/24 • Number of events 40 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Injection site reaction
|
50.0%
12/24 • Number of events 50 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
3/24 • Number of events 18 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Number of events 17 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Number of events 7 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Pyrexia
|
41.7%
10/24 • Number of events 31 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Infections and infestations
Skin infection
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
General disorders
Ulcer
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER