Trial · NCT02257567
Outcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 78
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Percentage of Participants With Adverse Events (AEs) | From the study start up to the end of the study (up to approximately 84 months) | Safety population consisted of all ITT participants from Phase Ib who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs | From Month 37 to Month 84 (up to approximately 47 months) | Safety population consisted of all ITT participants from Arms G+H (Phase II NF Cohort) who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Baseline up to approximately Month 24 | Safety population consisted of all ITT participants from Cohort 1a (Phase Ib) who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab | Baseline up to approximately Month 24 | Safety population consisted of all ITT participants from Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point. | percentage of participants | NUMBER |
| PRIMARY | Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized) | From Month 37 to Month 84 (up to approximately 47 months) | Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint. | percentage of participants | NUMBER |
| PRIMARY | Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC) | 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II Randomized and NF cohorts irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| PRIMARY | Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC | 6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks) | ITT population included all randomized participants in Arm H (Phase II NF Cohort) irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| PRIMARY | Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (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 | PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point. | ng*day/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) 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 | PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point. | nanograms per milliliters (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Arm G (Phase II NF Cohort): Systemic Clearance (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 outcome measure (OM) was based on sponsor's discretion however, sponsor opted to not collect data for this OM. | ||
| PRIMARY | Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (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 | Phase II: Percentage of Participants With AEs | From the study start up to the end of the study (up to approximately 84 months) | Safety population consisted of all ITT participants from Phase II who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin | Baseline to approximately Month 24 | Safety population consisted of all ITT participants from Arms A and C (Phase II) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab | Baseline to approximately Month 24 | Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator | 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC | 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II Expansion Cohorts and Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Phase II: Percentage of Participants With Objective Response (OR) at PRA Based on PET-CT as Determined by Investigator | 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Phase II: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC | 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator | 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC | 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
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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