Trial · NCT03128411
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 37 of 37
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Laboratory Abnormalities, Chemistry: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 | 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 |
| SECONDARY | Number of Participants With Laboratory Abnormalities, Hematology: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 | 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 |
| SECONDARY | Number of Participants With Laboratory Abnormalities, Coagulation: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 | From first dose and up to 12 March 2019; maximum of 22 months, approximately | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Vital Signs Findings | 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 |
| SECONDARY | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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 |
| SECONDARY | Number of Participants Assessed for Left Ventricular Ejection Fraction | At end of treatment for patients who discontinued treatment post initial dose (up to 12 March 2019) | As-treated population included all enrolled participants who received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Major Molecular Response (MMR) at Months 3, 6, 9 and 18 | Month 3, 6, 9 and 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 Molecular Response 1 (MR1) at Month 3 | Month 3 | 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 Molecular Response 2 (MR2) at Month 6 | Month 6 | 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 Molecular Response 4.0 (MR4.0) and Molecular Response 4.5 (MR4.5) at Months 3, 6, 9 and 12 | Months 3, 6, 9 and 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 | Cumulative Incidence of 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. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Molecular Response 4.0 (MR4.0) 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. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Molecular Response 4.5 (MR4.5) 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. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | 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 | Cumulative Incidence of Transformation to Accelerated Phase (AP) and Blast Phase (BP) 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. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With BCR-ABL Mutation at Treatment Discontinuation | Maximum up to 44 months of treatment | 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 participants with mutation testing. | 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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