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Trial · NCT04971226

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKIAt 48 weeksThe Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMajor Molecular Response at Week 96at 96 weeks (96 weeks after last patient first dose)
SECONDARYTime to Discontinuation of Study Treatment Due to Adverse Events (TTDAE)96 weeks after last patient first dose
SECONDARYMajor Molecular Response at Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYMajor Molecular Response by Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYMR4.0 at Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYMR4.5 at All Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYMR4.0 by Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYMR4.5 by All Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYComplete Hematological Response (CHR) at All Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYComplete Hematological Response (CHR) by All Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYPercentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported laterThe Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization and who had a valid bone marrow examination at week 48.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of MMRPlanned total follow-up duration of 5 years
SECONDARYDuration of MR4.0Planned total follow-up duration of 5 years
SECONDARYDuration of MR4.5Planned total follow-up duration of 5 years
SECONDARYTime to First MMRPlanned total follow-up duration of 5 years
SECONDARYTime to First MR4.0Planned total follow-up duration of 5 years
SECONDARYTime to First MR4.5Planned total follow-up duration of 5 years
SECONDARYBCR-ABL1≤1% at Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years
SECONDARYBCR-ABL1≤1% by Scheduled Data Collection Time PointsPlanned total follow-up duration of 5 years

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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