Trial Outcomes & Findings for Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery (NCT NCT00290355)

Last Updated: 2020-01-02

Results Overview

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

182 participants

Primary outcome timeframe

Over a median follow-up time of 28 months post-Dose 1

Results posted on

2020-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	GSK 249553 Group Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Overall Study STARTED	122	60
Overall Study COMPLETED	105	55
Overall Study NOT COMPLETED	17	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK 249553 Group Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Overall Study Serious adverse event	7	4
Overall Study Study product reactogenicity	1	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Migrated / moved from the study area	1	0
Overall Study Lost to Follow-up	3	1
Overall Study Other	2	0

Baseline Characteristics

Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=60 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Total n=182 Participants Total of all reporting groups
Age, Continuous	62.5 Years STANDARD_DEVIATION 7.85 • n=5 Participants	62.6 Years STANDARD_DEVIATION 8.88 • n=7 Participants	62.53 Years STANDARD_DEVIATION 8.18 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	53 Participants n=7 Participants	159 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	122 Participants n=5 Participants	60 Participants n=7 Participants	182 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over a median follow-up time of 28 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration. This analysis was based on the confirmed NSCLC recurrence so that patients withdrawn before imaging were removed.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=114 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=57 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence	37 Participants	24 Participants

SECONDARY outcome

Timeframe: At 6, 12, 18, 24 and 30 months after enrolment

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=114 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=57 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Percentage of Patients With Disease Recurrence Recurrence at Month 6	89.1 Percentage of Patients	91.5 Percentage of Patients
Percentage of Patients With Disease Recurrence Recurrence at Month 12	78.6 Percentage of Patients	70.8 Percentage of Patients
Percentage of Patients With Disease Recurrence Recurrence at Month 18	72.4 Percentage of Patients	62.0 Percentage of Patients
Percentage of Patients With Disease Recurrence Recurrence at Month 24	68.8 Percentage of Patients	58.3 Percentage of Patients
Percentage of Patients With Disease Recurrence Recurrence at Month 30	63.8 Percentage of Patients	58.3 Percentage of Patients

SECONDARY outcome

Timeframe: Over a median follow-up time of 44 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=60 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS)	49 Participants	29 Participants

SECONDARY outcome

Timeframe: Over a median follow-up time of 44 months post-Dose 1

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Overall Survival (OS) was based on total number of deaths, irrespective of cause of death. Non-small-cell Lung Cancer Overall Survival (NSCLC-OS) was based on total number of deaths due to lung cancer; deaths due to other or to unknown causes were censored appropriately.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=60 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Participants Who Died - Overall Survival (OS) Deaths, any cause	36 Participants	21 Participants
Number of Participants Who Died - Overall Survival (OS) Deaths, NSCLC-related	27 Participants	13 Participants

SECONDARY outcome

Timeframe: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.

A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 27.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=119 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=57 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects Seropositive Against MAGE-A3 Day 0	9 Participants	6 Participants
Number of Subjects Seropositive Against MAGE-A3 Week 6	88 Participants	4 Participants
Number of Subjects Seropositive Against MAGE-A3 Week 12	98 Participants	5 Participants
Number of Subjects Seropositive Against MAGE-A3 Month 9	75 Participants	2 Participants
Number of Subjects Seropositive Against MAGE-A3 Month 18	56 Participants	2 Participants
Number of Subjects Seropositive Against MAGE-A3 Month 24	52 Participants	1 Participants
Number of Subjects Seropositive Against MAGE-A3 Month 30	44 Participants	2 Participants
Number of Subjects Seropositive Against MAGE-A3 FU visit	25 Participants	1 Participants

SECONDARY outcome

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=119 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=57 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Anti- MAGE-A3 Antibody Concentrations Day 0	16.9 EL.U/mL Interval 14.4 to 19.8	17.8 EL.U/mL Interval 13.8 to 23.0
Anti- MAGE-A3 Antibody Concentrations Week 6	120.1 EL.U/mL Interval 88.1 to 163.6	17.0 EL.U/mL Interval 13.4 to 21.5
Anti- MAGE-A3 Antibody Concentrations Week 12	1017.4 EL.U/mL Interval 793.6 to 1304.4	18.7 EL.U/mL Interval 13.8 to 25.2
Anti- MAGE-A3 Antibody Concentrations Month 9	505.9 EL.U/mL Interval 404.1 to 633.3	14.7 EL.U/mL Interval 13.0 to 16.6
Anti- MAGE-A3 Antibody Concentrations Month 18	673.7 EL.U/mL Interval 508.0 to 893.6	14.7 EL.U/mL Interval 13.0 to 16.6
Anti- MAGE-A3 Antibody Concentrations Month 24	627.5 EL.U/mL Interval 464.8 to 847.1	14.0 EL.U/mL Interval 13.0 to 15.0
Anti- MAGE-A3 Antibody Concentrations Month 30	783.0 EL.U/mL Interval 571.8 to 1072.2	14.8 EL.U/mL Interval 12.9 to 16.8
Anti- MAGE-A3 Antibody Concentrations FU visit	187.8 EL.U/mL Interval 118.4 to 297.9	16.1 EL.U/mL Interval 10.2 to 25.4

SECONDARY outcome

A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 100.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=115 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=55 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects Seropositive Against Protein D (PD) Antigens Week 6	100 Participants	19 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Week 12	99 Participants	20 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Month 9	75 Participants	12 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Month 18	56 Participants	11 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Month 24	52 Participants	7 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Month 30	43 Participants	8 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens FU visit	26 Participants	0 Participants
Number of Subjects Seropositive Against Protein D (PD) Antigens Day 0	45 Participants	16 Participants

SECONDARY outcome

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=115 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=55 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Anti-protein D (Anti-PD) Antibody Concentrations Day 0	92.2 EL.U/mL Interval 78.6 to 108.0	71.6 EL.U/mL Interval 60.9 to 84.2
Anti-protein D (Anti-PD) Antibody Concentrations Week 6	711.7 EL.U/mL Interval 539.4 to 939.1	78.9 EL.U/mL Interval 65.6 to 94.8
Anti-protein D (Anti-PD) Antibody Concentrations Week 12	2694.0 EL.U/mL Interval 2179.6 to 3329.9	87.7 EL.U/mL Interval 71.6 to 107.5
Anti-protein D (Anti-PD) Antibody Concentrations Month 18	2029.0 EL.U/mL Interval 1591.2 to 2587.1	85.9 EL.U/mL Interval 64.0 to 115.3
Anti-protein D (Anti-PD) Antibody Concentrations Month 24	1587.7 EL.U/mL Interval 1197.2 to 2105.5	78.9 EL.U/mL Interval 55.4 to 112.4
Anti-protein D (Anti-PD) Antibody Concentrations Month 30	2018.4 EL.U/mL Interval 1486.6 to 2740.4	78.8 EL.U/mL Interval 59.3 to 104.6
Anti-protein D (Anti-PD) Antibody Concentrations FU visit	812.6 EL.U/mL Interval 513.9 to 1284.9	50.0 EL.U/mL Interval 50.0 to 50.0
Anti-protein D (Anti-PD) Antibody Concentrations Month 9	1455.8 EL.U/mL Interval 1137.0 to 1864.0	88.3 EL.U/mL Interval 65.9 to 118.4

SECONDARY outcome

Timeframe: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)

Responders were patients with at least 5x10-⁶ increase in minimal CD4 precursor frequency versus baseline. Any = at least one post treatment time point.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=37 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=14 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Week 6	8 Participants	2 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Week 12	7 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Month 9	0 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Month 18	2 Participants	0 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Month 24	1 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Month 30	2 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response FU visit	2 Participants	0 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response Any	15 Participants	1 Participants

SECONDARY outcome

Responders were patients with at least 5x10-⁶ increase in minimal CD8 precursor frequency versus baseline. Any = at least one post treatment time point.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=34 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=16 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Week 12	1 Participants	0 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Month 9	3 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Week 6	2 Participants	3 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Month 18	3 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Month 24	0 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Month 30	1 Participants	0 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response FU visit	1 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response Any	9 Participants	6 Participants

SECONDARY outcome

Timeframe: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60

Responders are patients with at least 5x10-⁶ increase in minimal CD4 or CD8 precursor frequency versus baseline. Any = at least one post treatment time point.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=40 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=18 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Week 6	10 Participants	5 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Week 12	8 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Month 9	3 Participants	2 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Month 24	1 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Month 30	2 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Month 60	2 Participants	1 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Any	21 Participants	7 Participants
Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response Month 18	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Over a median follow up time of 86 months

Population: Analysis was performed on the Total Treated cohort Gene Signature set which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test.

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. Gene expression profiling was performed by qRT-PCR in primary tumor samples taken at the time of resection of the tumor, and thus before any study treatment. Gene signature positive (GS+) and negative (GS-) profiles were assessed with a 61-set gene signature (GS) and a classifier which were defined in the Phase II melanoma EORTC 16032-18031 study.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=106 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=51 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature GS+	13 Participants	9 Participants
Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature GS-	31 Participants	12 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period, across doses

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=121 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=58 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	116 Participants	36 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	59 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	96 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	66 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	91 Participants	19 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	52 Participants	4 Participants

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period, across doses

Assessed solicited general symptoms were fatigue, headache, myalgia, nasea, rigors/chills, sweating/diaphoresis, temperature \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 4 Fatigue = Bedridden or disabling. Grade 4 Headache, Myalgia = Disabling. Grade 3 Nausea = No significant intake, requiring i.v. fluids. Grade 3 Rigors/Chills = Not responsive to narcotic medication. Grade 2 Sweating/Diaphoresis = Frequent or drenching. Grade 4 Vomiting = Requiring parenteral nutrition; or physiologic consequences requiring intensive care; haemodynamic collapse. Grade 3 fever = fever higher than (\>) 40.0 °C for more than 24 hours. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=121 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=58 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Fatigue	87 Participants	32 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 4 Fatigue	2 Participants	1 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Fatigue	78 Participants	23 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Headache	81 Participants	24 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 4 Headache	1 Participants	0 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Headache	69 Participants	16 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Myalgia	90 Participants	29 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 4 Myalgia	5 Participants	1 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Myalgia	77 Participants	24 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Nausea	46 Participants	18 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 3 Nausea	1 Participants	0 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Nausea	42 Participants	15 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Rigors/Chills	62 Participants	13 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 3 Rigors/Chills	8 Participants	0 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Sweating/Diaphoresis	62 Participants	19 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 2 Sweating/Diaphoresis	25 Participants	9 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Sweating/Diaphoresis	53 Participants	16 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Temperature	45 Participants	8 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 3 Temperature	0 Participants	0 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Temperature	40 Participants	3 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Any Vomiting	16 Participants	9 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Grade 4 Vomiting	0 Participants	0 Participants
Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms Related Vomiting	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) post-vaccination period

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=60 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	95 Participants	50 Participants

SECONDARY outcome

Timeframe: Throughout the study (Day 0 - Month 86)

Population: The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=60 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Serious Adverse Events (SAEs)	41 Participants	21 Participants

SECONDARY outcome

Timeframe: At Month 6, Month 12, Month 18, Month 24 and Month 30

Population: The analyses were performed on the Total Treated cohort gene signature (GS) set, which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test and with data available for the considered assay.

The parameters analysed were Protein, Red Blood Cells (RBC) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=100 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=50 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 6 · Normal	100 Participants	50 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 12 · Normal	86 Participants	38 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 18 · Normal	72 Participants	33 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 30 · Normal	55 Participants	23 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters Protein, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 6 · Normal	100 Participants	50 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 12 · Normal	86 Participants	38 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 18 · Normal	72 Participants	33 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 30 · Normal	55 Participants	23 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters RBC, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 6 · Normal	100 Participants	50 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 12 · Normal	86 Participants	38 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 18 · Normal	72 Participants	33 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 30 · Normal	55 Participants	23 Participants
Number of Subjects With Normal and Abnormal Urinalysis Parameters WBC, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 6, Month 12, Month 18, Month 24 and Month 30

The parameters analysed were Basophils (BAS), Eosinophils (EOS), Haemoglobin (HGB), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC), Sedimentations rate (SED) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=122 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=59 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters BAS, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters EOS, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters HGB, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 6 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 12 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 18 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 24 · Normal	119 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 30 · Normal	109 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Normal values at Baseline, Month 30 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 6 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 12 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 18 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 24 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 30 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters MON, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 30 · Normal	110 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters NEU, Normal values at Baseline, Month 30 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters PLA, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters RBC, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 30 · Normal	111 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters SED, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 6 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 12 · Normal	121 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 18 · Normal	122 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 24 · Normal	120 Participants	59 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 30 · Normal	110 Participants	51 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters WBC, Normal values at Baseline, Month 30 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Hematological Parameters LYM, Abnormal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 6, Month 12, Month 18, Month 24 and Month 30

The parameters analysed were Albumin (ALB), Bicarbonate (BIC), Blood urea nitrogen (BUN), Calcium (CAL), Chloride (CHL), Cholesterol (CHO), Creatinine (CREA), Glucose (GLU), Magnesium (MAG), Phosphate (PHO), Potassium (POT), Sodium (SOD), Total protein (TPROT), Total bilirubin (TBIL), Triglycerides (TRIG) and Uric acid (UAC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.

Outcome measures

Outcome measures
Measure	GSK 249553 Group n=97 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of GSK 249553 vaccine, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.	Placebo Group n=45 Participants Male and female patients at least 18 years of age, with resectable non-small-cell lung cancer (NSCLC), who received 13 doses of placebo, administered intramuscularly in the deltoid or lateral regions of the thighs, alternatively on the right and left sides, according to the following schedule: 5 doses at 3-week intervals, followed by 8 doses at 3-month intervals.
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 12 · Normal	85 Participants	33 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 12 · Abnormal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters ALB, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BIC, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters BUN, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 6 · Normal	91 Participants	43 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 6 · Abnormal	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 12 · Normal	80 Participants	33 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 12 · Abnormal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 18 · Normal	67 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 24 · Normal	65 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 24 · Abnormal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 30 · Normal	53 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 6 · Normal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 6 · Abnormal	3 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 12 · Normal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 12 · Abnormal	3 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 18 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 18 · Abnormal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 24 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 24 · Abnormal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 30 · Normal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CAL, Abnormal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHL, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 6 · Normal	96 Participants	44 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 6 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 12 · Normal	85 Participants	33 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 18 · Normal	70 Participants	29 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 24 · Normal	68 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 30 · Normal	55 Participants	21 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 6 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 12 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 18 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 24 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 30 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CHO, Abnormal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 12 · Normal	84 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 12 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 18 · Normal	69 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 18 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters CREA, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 6 · Normal	94 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 6 · Abnormal	2 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 12 · Normal	83 Participants	32 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 12 · Abnormal	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 18 · Normal	70 Participants	28 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 18 · Abnormal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 24 · Normal	67 Participants	29 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 24 · Abnormal	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 30 · Normal	54 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Normal values at Baseline, Month 30 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 6 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 12 · Normal	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 18 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 24 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters GLU, Abnormal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 6 · Normal	96 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 12 · Normal	83 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 12 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 24 · Normal	68 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 24 · Abnormal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Abnormal values at Baseline, Month 6 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Abnormal values at Baseline, Month 12 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters MAG, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters PHO, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 6 · Normal	96 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 6 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters POT, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 24 · Normal	67 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 24 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters SOD, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 6 · Normal	97 Participants	45 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 12 · Normal	85 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 18 · Normal	70 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TPROT, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 24 · Normal	68 Participants	31 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 30 · Normal	55 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TBIL, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 6 · Normal	97 Participants	44 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 12 · Normal	85 Participants	33 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 18 · Normal	70 Participants	29 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 24 · Normal	68 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 30 · Normal	55 Participants	21 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Normal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 6 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 12 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 18 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 24 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 24 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 30 · Normal	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters TRIG, Abnormal values at Baseline, Month 30 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 6 · Normal	95 Participants	44 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 6 · Abnormal	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 12 · Normal	83 Participants	34 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 12 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 18 · Normal	69 Participants	30 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 24 · Normal	68 Participants	29 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 24 · Abnormal	0 Participants	2 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 30 · Normal	54 Participants	22 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Normal values at Baseline, Month 30 · Abnormal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 6 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 6 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 12 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 12 · Abnormal	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 18 · Normal	1 Participants	0 Participants
Number of Subjects With Normal and Abnormal Biochemical Parameters UAC, Abnormal values at Baseline, Month 18 · Abnormal	0 Participants	0 Participants

Adverse Events

GSK 249553 Group

Serious events: 41 serious events

Other events: 120 other events

Deaths: 54 deaths

Placebo Group

Serious events: 21 serious events

Other events: 53 other events

Deaths: 26 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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