Trial · NCT04182204
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage 1: Number of Participants With Adverse Events (AEs) | From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months) | Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stage 1: Number of Participants With Peripheral Neuropathy (PN) | From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months) | Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stage 2: Overall Survival (OS) | From randomization to death (Up to approximately 34 months) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Stage 1 and Stage 2: Progression-free Survival (PFS) | From randomization to first occurrence of PD or death (Up to approximately 34 months) | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | months | MEDIAN |
| SECONDARY | Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment | Up to approximately 8.5 months | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment | Up to approximately 8.5 months | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator | Up to approximately 34 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 2: Duration of Response (DOR) | Up to approximately 34 months | DOR-evaluable population included all participants who had an objective response (CR or PR). | months | MEDIAN |
| SECONDARY | Stage 1 and Stage 2: Event-free Survival (EFSeff) | Up to approximately 34 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | months | MEDIAN |
| SECONDARY | Stage 2: Time to Deterioration in Physical Functioning as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30) | Up to approximately 34 months | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Stage 2: Time to Deterioration in Fatigue Scale as Measured by the EORTC QLQ-C30 | Up to approximately 34 months | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Stage 2: Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Subscale (FACT-Lym LymS) | Up to approximately 34 months | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Stage 2: Change From Baseline in Physical Functioning as Measured by EORTC QLQ-C30 | Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months) | ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Participants may have been lost to follow-up/did not complete the specified visit during the study. | score on a scale | MEAN |
| SECONDARY | Stage 2: Change From Baseline in Fatigue Scale as Measured by EORTC QLQ-C30 | Baseline, Day 1 of Cycles 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months) | ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified time point. Participants may have been lost to follow-up/did not complete the specified visit during the study. | score on a scale | MEAN |
| SECONDARY | Stage 2: Change From Baseline in FACT-Lym LYMS Scores | Baseline, Day 1 of Cycle 2, 3, 5 and 7 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months) | ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified time point. Participants may have been lost to follow-up/did not complete the specified visit during the study. | score on a scale | MEAN |
| SECONDARY | Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item (FACT/GOG-NTX-12) Scores | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7 and 8 (Cycle length= 21 days), end of treatment, long-term follow-up visits every two months (up to approximately 34 months) | Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. Participants may have been lost to follow-up/did not complete the specified visit during the study. | score on scale | MEAN |
| SECONDARY | Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Physical Functioning Scale | Up to approximately 34 months | ITT population included all randomized participants in Stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 2: Percentage of Participants With Clinically Meaningful Improvement in EORTC QLQ-C30 Fatigue Scale | Up to approximately 34 months | ITT population included all randomized participants in Stage 2. | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04182204/outcomes