Trial · NCT03128411
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 37
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 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) by Month 12 | Up to Month 12 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) by Month 18 | Up to Month 18 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 | Up to Month 12 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Maintaining Major Molecular Response (MMR) at Month 36 | At Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had MMR. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36 | At Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had CCyR. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Event Free Survival (EFS) at Month 36 | Up to Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Probability of Overall Survival (OS) at Month 36 | Up to Month 36 | The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Trough Plasma Concentrations of Bosutinib | Pre-dose on Day 1, Day 28, Day 56, Day 84 | The PK population will be defined as any patient in the safety population of patients who had at least 1 concentration of bosutinib on-treatment. | Nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against each categories/levels respectively. | ng/mL | MEAN |
| SECONDARY | Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against each categories/levels respectively. | ng/mL | MEAN |
| SECONDARY | Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against each categories/levels respectively. | ng/mL | MEAN |
| SECONDARY | Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase | Pre-dose on Day 28, Day 56 and Day 84 | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against each categories/levels respectively. | ng/mL | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia | Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest | PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of number analyzed against Yes and No categories respectively. | ng/mL | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs): National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or Higher | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | 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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