Trial · NCT02257567
Outcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
61 to 78 of 78
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and obinutuzumab. | day*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and rituximab. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase II: AUCinf of Bendamustine and Rituximab in Arms B and D | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for rituximab. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and F | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and obinutuzumab. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Arm H (Phase II NF Cohort): AUC of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks | As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM. | ||
| SECONDARY | Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and rituximab. | mL/day/kg | GEOMETRIC_MEAN |
| SECONDARY | Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and obinutuzumab. | mL/day/kg | GEOMETRIC_MEAN |
| SECONDARY | Phase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms A and B who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for pola and rituximab. | Liters per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Phase II: CL of Bendamustine and Rituximab in Arms B and D | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for rituximab. | L/h | GEOMETRIC_MEAN |
| SECONDARY | Phase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for pola and obinutuzumab. | L/h | GEOMETRIC_MEAN |
| SECONDARY | Arm H (Phase II NF Cohort): CL of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM. | ||
| SECONDARY | Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and rituximab. | mL/kg | GEOMETRIC_MEAN |
| SECONDARY | Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab. | mL/kg | MEAN |
| SECONDARY | Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and rituximab. | L | GEOMETRIC_MEAN |
| SECONDARY | Phase II: Vss of Bendamustine and Rituximab in Arms B and D | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for rituximab. | L | GEOMETRIC_MEAN |
| SECONDARY | Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F | Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) | PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and obinutuzumab. | L | GEOMETRIC_MEAN |
| SECONDARY | Arm H (Phase II NF Cohort): Vss of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM. | ||
| SECONDARY | Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F | Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall) | ITT population included all randomized participants in Arms A-F (Phase II) irrespective of whether or not they received the study treatment. 'Overall Number Analysed' =number of participants with data available for analysis. 'Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Participants from Arm F did not answer a sufficient number of questions at both baseline and end of treatment visit therefore the average score could not be calculated. | Points on 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.
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