Trial · NCT00101660
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR) | 2 years | All imatinib-resistant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Number of Imatinib-intolerant Participants With MCyR | Baseline to 2 years | All imatinib-intolerant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months | 12 and 24 Months | Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR. | Percentage of participants | NUMBER |
| SECONDARY | Median Time From First Dosing Date to Date of MCyR | Baseline (within 4 weeks of Day 1) and every 12 weeks | Population is limited to responders (those who acheived MCyR) only | Months | MEDIAN |
| SECONDARY | Number of Participants With Complete Hematologic Response (CHR) | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | All participants who received treatment. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months | 12 and 24 months | Population limited to responders (those achieving CHR) only | Percentage of participants | NUMBER |
| SECONDARY | Median Time From First Dosing Until CHR | Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study | Population limited to responders (those achieving CHR) only | Months | MEDIAN |
| SECONDARY | Number of Participants With Major Molecular Response (MMR) | Baseline to 2 years | All participants who received treatment. | Participants | NUMBER |
| SECONDARY | Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores | Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria. | Number of participants with assessments at baseline and timepoint | Participants | NUMBER |
| SECONDARY | Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE | Continuously, from baseline through 2 years | All imitanib-intolerant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE | Continuously, from baseline through 2 years | All imitanib-resistant participants who received treatment. | Participants | NUMBER |
| SECONDARY | Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib | Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose. | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00101660/outcomes