Outcomes18

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

1 to 18 of 18

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population	Randomization up to 6 months	Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.	percentage of participants	NUMBER
SECONDARY	Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population	Randomization up to 2 years	Participants were analyzed based on the treatment they were randomized to receive.	percentage of participants	NUMBER
SECONDARY	Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population	Randomization up to 2 years	Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.	percentage of participants	NUMBER
SECONDARY	Median Time to Major Hematologic Response (MaHR) - Randomized Population	Day 1 up to 6 months (time of primary endpoint), 2 years	Participants were analyzed based on the treatment they were randomized to receive.	Months	MEDIAN
SECONDARY	Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study	Day 1 up to 5 years	Participants who achieved a MaHR during the study.	Months	MEDIAN
SECONDARY	Percent of Participants With Overall Hematologic Response - Randomized Population	Randomization up to 6 Months, 2 Years	Participants were analyzed based on the treatment they were randomized to receive.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population	Randomization up to 6 months, 2 years	Participants were analyzed based on the treatment they were randomized to receive.	participants	NUMBER
SECONDARY	Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population	Randomization up to 6 Months, 2 Years	Participants were analyzed based on the treatment they were randomized to receive.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Best Cytogenic Response (CyR) - Randomized Population	Randomization up to 6 Months, 2 Years	Participants were analyzed based on the treatment they were randomized to receive.	participants	NUMBER
SECONDARY	Median Progression Free Survival (PFS) - Randomized Population	Randomization up to 5 Years	Participants were analyzed based on the treatment they were randomized to receive.	Months	MEDIAN
SECONDARY	Median Overall Survival (OS) - Randomized Population	Randomization up to 5 Years	Participants were analyzed based on the treatment they were randomized to receive.	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population	24 months, 36 months, 48 months, 60 months	Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants	Day 1 to Year 7	All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.	participants	NUMBER
SECONDARY	Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants	Baseline to Year 2	All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Those participants who did not have a parameter reported at baseline are indicated.	participants	NUMBER
SECONDARY	Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations	Day 1 up to Year 7	All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.	participants	NUMBER
SECONDARY	Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants	Baseline to Year 2	All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.	participants	NUMBER
SECONDARY	Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants	Baseline to Year 2	All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.	participants	NUMBER
SECONDARY	Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants	Baseline up to Year 2	All participants who received at least one dose of study drug and had appropriate ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.	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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