Trial · NCT02130557
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Major Molecular Response (MMR) at Month 12 | Month 12 | Modified intent-to-treat (mITT) population included all randomized participants with Philadelphia chromosome positive (Ph+) CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies greater than (\>) 0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | Up to Month 18 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | Month 48 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization and who achieved MMR (responders). Here, Overall number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Up to Month 12 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | Month 48 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization and who achieved CCyR (responders). Here, N signifies number of participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Event Free Survival (EFS) Events | Up to Month 60 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate | Up to Month 60 | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies \>0 with study drug assignment designated according to initial randomization. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | Pharmacokinetic (PK) population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and number analyzed (n) signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | nanogram per milliliter (ng/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib | Pre-dose on Days 28, 56 and 84 | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib | Pre-dose on Days 28, 56 and 84 | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib | Pre-dose on Days 28, 56 and 84 | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | ng/mL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Vital Signs Abnormalities | Baseline up to end of treatment (up to Month 60) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, N signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03 | Baseline up to end of treatment (up to Month 60) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to end of treatment (up to Month 60) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, N signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Baseline up to end of treatment (up to Month 60) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0) | Baseline up to end of treatment (up to Month 60) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
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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