Trial · NCT00480025
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| PRIMARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | percent probability | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | percent probability | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | percent probability | MEDIAN |
| SECONDARY | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population | Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | events/person-years | NUMBER |
| SECONDARY | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120) | The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Health-related Quality of Life (HQL) Scores | At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120 | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Scores on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00480025/outcomes