Trial · NCT02420821
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization. | percentage of participants | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died of Any Cause in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) in ITT Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the PD-L1-Selected Population. | percentage of participants | NUMBER |
| SECONDARY | OS in PD-L1-Selected Population | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by an IRC According to RECIST v1.1 in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the PD-L1-Selected Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ORR-Evaluable Population, which included all participants in the ITT population with measurable disease at baseline, as determined by the investigator. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on DOR-Evaluable Population, which included all participants with a CR/PR in the ORR-Evaluable Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ORR-Evaluable Population. | percentage of participants | NUMBER |
| SECONDARY | DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the DOR-Evaluable Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ORR-Evaluable Population. | percentage of participants | NUMBER |
| SECONDARY | DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on DOR-Evaluable Population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | percentage of participants | NUMBER |
| SECONDARY | PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) | Analysis was performed on the ITT Population. | months | MEDIAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02420821/outcomes