Trial · NCT01646021
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months) | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Duration of Response | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Months | MEDIAN |
| SECONDARY | Time-to-Next Treatment | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival 2 | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Weeks | MEDIAN |
| SECONDARY | Number of Participants Affected With Treatment-emergent Adverse Events | Time from first dose of study drug until the last dose date + 30 days or the start of a subsequent anti-neoplastic therapy, whichever occur earlier (Approximately up to 4 years) | Safety population included all randomized participants who received at least 1 dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time to Response | Approximately up to 2.8 years | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Extent of Exposure of Time | Approximately up to 46.8 months | Safety Analyses Set (SAS) population includes all the randomized participants who received at least 1 dose of study agent (ibrutinib or temsirolimus) during the treatment phase. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | One Year Survival Rate | Month 12 | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Area Under the Plasma Concentration of Ibrutinib During Steady State (AUC-ss) | Cycle 1 and 2 (Day 1): Predose, 1, 2, 4 hr. postdose; Cycle 3 (day 1): Predose (Each cycle is of 21 days) | Pharmacokinetic analysis set included the participants who had received one dose of study drug had at least 1 pharmacokinetic sample obtained post-treatment. | nanogram*hour per milliliter (ng*h/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Biomarkers That Alter B-cell Receptor (BCR) Signaling or Activate Alternative Signaling Pathways and to Explore Their Association With Response or Resistance to Ibrutinib | Approximately up to 28.2 months | Participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Hospitalizations Reported Related Medical Resource Utilization Information (MRUI) | Approximately up to 28.2 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Hospitalizations | MEAN |
| OTHER_PRE_SPECIFIED | Number of Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI) | Approximately up to 28.2 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Emergency room visits | MEAN |
| OTHER_PRE_SPECIFIED | Days of Hospitalization and Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI) | Approximately up to 28.2 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Days | MEAN |
| OTHER_PRE_SPECIFIED | The Mean Change From Baseline in Euro QoL Five-Dimension (EQ-5D-5L) Scores for Each Post Baseline Assessment | Baseline, Cycle 2, 3, 4, 5, 6, 7, 8, 11, 14, 17, 20, 28, 36 and End of treatment (approximately up to 23 months) | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants evaluated for this outcome measure. | Units 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01646021/outcomes