Trial · NCT00103844
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Cytogenetic Response (MCyR) at Week 12 | Week 12 | All randomized subjects | Participants | NUMBER |
| SECONDARY | MCyR at Any Time Prior to Crossover | Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements. | Participants | NUMBER | |
| SECONDARY | Duration of MCyR at 12 Months and 18 Months | 12 months, 18 months | percentage of participants. | NUMBER | |
| SECONDARY | Duration of MCyR at 24 Months | 24 Months | In the imatinib group, the 24 months timepoint was beyond the maximum observed time. | Percentage of Participants | NUMBER |
| SECONDARY | Time to MCyR Prior to Crossover | Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements. | Population consists of the number of responders in each treatment group | months | MEDIAN |
| SECONDARY | Complete Hematologic Response (CHR) at Any Time Prior to Crossover | Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements. | Participants | NUMBER | |
| SECONDARY | Duration of Complete Hematologic Response (CHR) | 12 months, 24 months | Number of participants achieving CHR in each treatment group | percentage of participants | NUMBER |
| SECONDARY | Time to CHR Prior to Crossover | Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements. | Number of participants achieving CHR in each treatment group | weeks | MEDIAN |
| SECONDARY | Major Molecular Response (MMR) | Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements. | Participants assessed for MMR only | participants | NUMBER |
| SECONDARY | CHR After Crossover | Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements. | Participants evaluable for response after crossover | Participants | NUMBER |
| SECONDARY | Cytogenetic Response After Crossover | every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements | Participants evaluable for after crossover response | Participants | NUMBER |
| SECONDARY | Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover | Continuously from baseline through 2 years | All treated participants | Participants | NUMBER |
| SECONDARY | Health-Related Quality of Life Prior to Crossover | Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date. | Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed. | Units on a Scale | NUMBER |
| SECONDARY | Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib | Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose. | Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report. | 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/NCT00103844/outcomes