Trial · NCT01798485
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
| SECONDARY | Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants with elevated LDH at screening | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as of 19 October 2015 | up to 36 months | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) as of 19 October 2015 | up to 36 months | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 | up to 36 months | Randomized participants who had a confirmed response | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants who had an elevated screening LDH | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | ||
| SECONDARY | Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | ||
| SECONDARY | Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015 | up to 36 months | Randomized participants | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Exploratory Biomarker Analyses | up to 36 months | Randomized | ||
| SECONDARY | Participants With Treatment-Emergent Adverse Events as of 23 December 2015 | up to 36 months | Safety population | participants | NUMBER |
| SECONDARY | Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial | Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | ||
| SECONDARY | Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial | Randomized participants |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01798485/outcomes