Trial · NCT01010061
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | Months | MEDIAN |
| PRIMARY | Percentage of Participants With Progression Free Survival Events | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) | Intent-to-treat population included all randomized participants. Patients without PFS events were censored. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data | Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months) | Intent-to-treat population included all randomized participants. Participants without PFS events were censored. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With End of Treatment Response (EOTR) | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Percentage of participants | NUMBER |
| SECONDARY | Event Free Survival | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Intent-to-treat population included all randomized participants. Patients without EFS events were censored. | Months | MEDIAN |
| SECONDARY | Overall Survival | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Intent-to-treat population included all randomized participants. Patients without OS events were censored. | Months | MEDIAN |
| SECONDARY | Duration of Response | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Molecular Remission at the End of Treatment | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded. | Percentage of participants | NUMBER |
| SECONDARY | Time to Re-Treatment/New-antileukemic Therapy | Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization) | Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored. | Months | MEDIAN |
| SECONDARY | Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb) | Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months) | PK population includes all participants with PK data available at the given time-point. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | unit on a scale | MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score | Baseline and Cycle 4 Day 1 (Cy4D1) | ITT population. Here, n signifies the number of participants who were evaluated for specified categories. | 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/NCT01010061/outcomes