Trial · NCT00482703
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment | Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day. | All treated participants | participants | NUMBER |
| SECONDARY | Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24 | Week 24 | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Time to Major Cytogenetic Response (MCyR) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Treated participants - responders | months | MEDIAN |
| SECONDARY | Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics | Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration. | Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report. | participants | NUMBER |
| SECONDARY | Duration of MCyR | from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death | Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table. | months | MEDIAN |
| SECONDARY | Time to CHR | time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met | Treated participants - responders | months | MEDIAN |
| SECONDARY | Duration of CHR | measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death | Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met | Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16. | months | MEDIAN |
| SECONDARY | Expression of BCR-ABL Gene Mutations of RNA (mRNA) | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | Treated participants | participants | NUMBER |
| SECONDARY | Mutational Spectrum of BCR-ABL | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | Treated participants | participants | NUMBER |
| SECONDARY | Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study | Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) | All treated participants | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table) | Months 0, 4, 8, 12, 16, 20, 24 | Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table) | Months 0, 4, 8, 12, 16, 20, 24 | Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table) | Months 0, 4, 8, 12, 16, 20, 24 | Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7) | 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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