Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T[year)]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.

The analysis was performed on the Total Treated population that included all the subjects who had received at least one dose of the study product.

OS was defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive were censored at the last visit they are known to be alive. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.

Overall survival data was not collected.

Lung-cancer specific survival was defined as defined as the interval from randomization to the date of death due to lung cancer; deaths due to other or unknown causes were censored at the date of death. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.

Lung-cancer specific survival data was not collected.

DFSS was defined as the interval from randomization to the date of first recurrence of disease or date of death due to lung cancer, whichever occurs first. Patients without recurrence or death due to lung cancer were censored at the date of last assessment. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.

Disease free-specific survival data was not collected.

Defined as the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurred first. The 5-year active follow-up period planned in the initial study protocol was cancelled per Protocol Amendment 2, hence this analysis was not performed.

The 5-Year Follow-Up Disease Free Survival data were not collected.

Unsolicited AEs covered 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.

This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.

Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.

Anti-PRAME antibody data was not collected.

Hematological and biochemical parameters assessed were tabulated by maximum grade versus baseline, by CTCAE = Common Terminology Criteria for Adverse Events version 4.0 (Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; Grade 5 = death; Grade Unknown) and by the type of abnormality (e.g. increased, decreased, prolonged, etc.). Some parameters (e.g. Anemia) already comprise within their definition the type of abnormality presented.

This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product and for whom blood results were available for the respective parameter assessed.

SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE.

This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.

Grading was done as per the Common Terminology Criteria for Adverse Events (CTCAE) of the U.S. National Cancer Institute, version 4.0. The intensity grades assessed were: 1, 2, 3, 4, 5 and Unknown.

This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.