Trial · NCT02415608
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | 30 days | All study participants are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ibrutinib Pharmacokinetics (PK) | 28 days | Because this study terminated with low total accrual, the funding sponsor elected not to analyze the samples for ibrutinib levels. There are no pharmacokinetics values on which to conduct the outcome analysis. | ||
| SECONDARY | Change of Mast Cell Burden | 2 years | The result was only calculated for those participants for whom a post-treatment mast cell level could be determined. | Percent reduction of mast cells | MEDIAN |
| SECONDARY | Serum Tryptase Levels | 2 years | Results were determined for all participants. | Percent reduction serum tryptase level | MEDIAN |
| SECONDARY | Total Symptom Score (TSS) | 30 days | Results were analyzed for all participants. | score on a scale | MEDIAN |
| SECONDARY | Change in Quality of Life (QoL) | 30 days | Results were analyzed for all participants. | score on a scale | MEDIAN |
| SECONDARY | Duration of Response (DoR) | 2 years | No participants achieved clinical response per protocol (minimum of any clinical improvement ≥ 12 weeks). On that basis, the overall duration of that response can not be determined. | ||
| SECONDARY | Time-to-Response (TTR) | 2 years | No participants achieved clinical response per protocol (minimum of any clinical improvement ≥ 12 weeks). On that basis, the time to achieve per-protocol clinical response can not be determined. | ||
| SECONDARY | Progression-free Survival (PFS) | 2 years | Results were analyzed for all participants. Values were censored at the last assessment if the participant was lost-to-follow-up or otherwise did not have a 2-year assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 26 months | The single patient receiving ibrutinib 560 mg/day was censored per protocol. | months | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02415608/outcomes