Trial · NCT02257567
Outcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 40 of 78
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Phase II: Percentage of Participants With OR 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. 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 CT Only 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 Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator | Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months) | 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 | DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC | Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months) | ITT population included all randomized participants in DLBCL Cohorts 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 | DLBCL Cohorts: Duration of Response (DOR) Based on PET-CT or CT Only as Determined by the Investigator | From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months) | ITT population included all randomized participants in DLBCL Cohorts 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. 'Overall Number Analyzed' are the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC | From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months) | ITT population included all randomized participants in DLBCL Cohorts 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. 'Overall Number Analyzed' are the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | DLBCL Cohorts: Progression Free Survival (PFS) Based on PET-CT or CT Only as Determined by the Investigator | From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months) | ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | DLBCL Cohorts: PFS Based on PET-CT or CT Only as Determined by the IRC | From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months) | ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | Phase II NF Cohort: 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) or last dose of study drug (up to approximately 23 weeks) | ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| SECONDARY | Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by Investigator | 6 to 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 Phase II NF Cohort 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 NF Cohort: 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) or last dose of study drug (up to approximately 23 weeks) | ITT population included all randomized participants in Phase II NF Cohort 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 NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the Investigator | Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort 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 NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the IRC | Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort 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 NF Cohort: DOR Based on PET-CT or CT Only as Determined by the Investigator | From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort 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. 'Overall Number Analyzed' are the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the IRC | From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort 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. 'Overall Number Analyzed' are the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator | From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the IRC | From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months]) | ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | Phase II NF Cohort: Event-Free Survival (EFS) Based on PET-CT or CT Only, as Determined by the Investigator | From Month 37 to Month 84 (up to approximately 47 months) | ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | Phase II NF Cohorts: Overall Survival (OS) | From Month 37 to Month 84 (up to approximately 47 months) | ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. | months | MEDIAN |
| SECONDARY | 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 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 G (Phase II NF Cohort) 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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