Trial · NCT02053610
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Randomization to clinical cutoff (median observation 59.4 months) | Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day. | months | MEDIAN |
| PRIMARY | Percentage of Participants With Progression Free Survival Events | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months) | ITT participants included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Event Free Survival | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day. | months | MEDIAN |
| SECONDARY | Overall Survival | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive. | months | MEDIAN |
| SECONDARY | Duration of Response | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff (median observation 59.4 months) | Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis. | percentage of participants | NUMBER |
| SECONDARY | Time to Re-Treatment/New Anti-leukemic Therapy | Randomization to clinical cutoff (median observation 59.4 months) | ITT population included all randomized participants. Participants who were reported as not having started re-treatment or new anti-leukemic therapy were censored at the last visit date they were assessed with regard to start of new treatment or the date of death. | months | MEDIAN |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified category. | unit on a scale | MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified category. | unit 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02053610/outcomes