Trial · NCT00978731
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 Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| PRIMARY | Number of Participants With Grade 3-4 Hematology Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Hematologic Response (CHR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | participants | NUMBER |
| SECONDARY | Median Number of Months of CHR (Kaplan Meier Method) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | months | MEDIAN |
| SECONDARY | Number of Participants With Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable. | participants | NUMBER |
| PRIMARY | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| SECONDARY | Median Number of Months of Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | months | MEDIAN |
| PRIMARY | Number of Participants With Dose Interruptions and Dose Reductions | From start of study to final assessment (up to 32.2 months). | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Best Cytogenetic Response | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable. | participants | NUMBER |
| SECONDARY | Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method) | Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | months | MEDIAN |
| SECONDARY | Median Number of Months of Overall Survival (OS) (Kaplan Meier Method) | Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | months | MEDIAN |
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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GET https://conductscience.org/api/trials/v1/NCT00978731/outcomes