Trial · NCT03128411
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 37 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Laboratory parameters include: Alanine aminotransferase (ALT) increased: Grade 3: \>5.0-20.0\*upper limit of normal (ULN),Grade 4:\>20.0\*ULN, Alkaline phosphatase (ALP) increased: Grade 3: \>5.0 - 20.0 x ULN, Grade 4: \>20.0 x ULN, Aspartate aminotransferase (AST) increased: Grade 3: \>5.0 - 20.0 \*ULN, Grade 4: \>20.0\*ULN. Blood bilirubin increased:Grade 3:\>3.0 - 10.0\*ULN,Grade 4: \>10.0\*ULN, creatine phosphokinase (CPK) increased: Grade 3: \>5\*ULN-10\*ULN, Grade 4: \>10\*ULN, Hyperglycemia: Grade 3: \>250-500 milligrams/deciliter (mg/dL), Grade 4: \>500 mg/dL. Hypermagnesemia: Grade 3: \>3.0-8.0 mg/dL, Grade 4: \>8.0 mg/dL, Hypokalemia: Grade 3: \<3.0-2.5 millimoles/ liter (mmol/L), Grade 4:\<2.5 mmol/L); Hyponatremia: Grade 3: \<130-120 mmol/L, Grade 4: \<120 mmol/L. Hypophosphatemia: Grade 3: \<2.0-1.0 mg/dL, Grade 4: \<1.0 mg/dL. Lipase increased: Grade 3:\>2.0-5.0\*ULN, Grade 4: \>5.0\*ULN. Serum amylase increased: Grade 3: \>2.0 - 5.0\*ULN, Grade 4: \>5.0\* ULN. |
| 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) | Laboratory parameters include: Anemia: Grade 3: hemoglobin (Hgb) \<8.0 g/dL, Grade 4: Life-threatening consequences; urgent intervention indicated, Lymphocyte count decreased: Grade 3: \<500 - 200/millimeter(mm)\^3, Grade 4: \<200/mm\^3, Neutrophil count decreased: Grade 3: \<1000 - 500/mm\^3, Grade 4: \<500/mm\^3, Platelet count decreased: Grade 3: \<50.0 - 25.0\*10\^9 /L, Grade 4: \<25.0\*10\^9 /L. White blood cell decreased: Grade 3: \<2.0 - 1.0\*10\^9 /L, Grade 4: \<1.0\*10\^9 /L. Only those rows in which at least 1 participant had data were reported. |
| 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 | Coagulation parameters include: APTT prolonged (Grade 3: \>2.5\*ULN and hemorrhage), and INR increased (Grade 3 \>2.5\*ULN). |
| 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) | Vital signs included: body weight Increase \>= 10% change from baseline and Decrease \>= 10% change from baseline, systolic blood pressure in millimeters of mercury (mmHg): \<80 mmHg and \>210 mmHg, diastolic blood pressure in mmHg: \<40 mmHg and \>130 mmHg, heart rate in beats per minute (bpm): \<40 bpm and \>150 bpm, temperature in degree Celsius (C): \<32 and \>40 degree C. |
| 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) | ECG parameters included: QTc corrected by Bazett's (QTcB) interval: \>500 msec (milliseconds), QTc corrected by Fridericia's (QTcF) interval: \>500 msec and \>450 msec (men) or \>470 msec (women). |
| 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) | Interpretation categories included: a) normal, b) abnormal, not clinically significant and c) abnormal, clinically significant. |
| Secondary | Percentage of Participants With Major Molecular Response (MMR) at Months 3, 6, 9 and 18 | Month 3, 6, 9 and 18 | A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder. |
| Secondary | Percentage of Participants With Molecular Response 1 (MR1) at Month 3 | Month 3 | MR1 is defined as \<= 10% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory. |
| Secondary | Percentage of Participants With Molecular Response 2 (MR2) at Month 6 | Month 6 | MR2 is defined as \<= 1% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory. |
| 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 | MR4.0 defined as either: detectable disease with \<= 0.01% BCR-ABL with a minimum of 9,800 ABL transcripts assessed by the central laboratory, or undetectable disease in cDNA with a minimum of 9,800 ABL transcripts assessed by the central laboratory. MR4.5 defined as either: detectable disease with \<= 0.0032% BCR-ABL with a minimum of 30,990 ABL transcripts assessed by the central laboratory or undetectable disease in cDNA with a minimum of 30,990 ABL transcripts assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder. |
| Secondary | Cumulative Incidence of Major Molecular Response (MMR) at Month 36 | At Month 36 | Percentage of participants with MMR at Month 36. Cumulative incidence of MMR was measured from first dose to the first date of response. Documented participants who did not have an MMR response were censored at the last molecular assessment. A MMR is defined as \<=0.1% BCR-ABL transcripts on the international scale, corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event. |
| Secondary | Cumulative Incidence of Molecular Response 4.0 (MR4.0) at Month 36 | At Month 36 | Percentage of participants with MR4.0 at month 36. Cumulative incidence of MR4.0, was measured from first dose to the first date of MR 4.0. Documented participants who did not have an MR4.0 response were censored at the last molecular assessment. MR4.0 defined as either 1) detectable disease with \<=0.01% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 9800 ABL transcripts specified by the central laboratory. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event. |
| Secondary | Cumulative Incidence of Molecular Response 4.5 (MR4.5) at Month 36 | At Month 36 | Percentage of participants with MR4.5 at Month 36. Cumulative incidence of MR 4.5 was measured from first dose to the first date of MR 4.5. Documented participants who did not have an MR4.5 response were censored at the last molecular assessment. MR 4.5 defined as either 1) detectable disease with \<=0.0032% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 30990 ABL transcripts specified by the central laboratory in the same volume of cDNA used to test for BCR-ABL. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event. |
| Secondary | Cumulative Incidence of Complete Cytogenetic Response (CCyR) at Month 36 | At Month 36 | Percentage of participants with CCyR at Month 36. Cumulative incidence of CCyR, was measured from first dose to the first date of CCyR. Documented participants who did not have a CCyR response were censored at the last cytogenetic assessment. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event. |
| Secondary | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Up to Month 36 | CHR is based on peripheral blood assessment: WBC \<=10\*10\^9/L, basophils \<5% in blood, no myelocytes, promyelocytes, myeloblasts in the blood differential, platelet count \<450\* 10\^9/L, spleen non-palpable. In the absence of extramedullary disease info, it was assumed that spleen was non-palpable. If CHR could not be assessed due to one or more missing components of CHR and participant had a MMR or a CCyR and all assessed components of CHR were within appropriate limits, then CHR was imputed using CCyR or MMR. CHR must be of at least 4 weeks in duration and confirmed by 2 assessments at least 4 weeks apart. |
| Secondary | Cumulative Incidence of Transformation to Accelerated Phase (AP) and Blast Phase (BP) at Month 36 | At Month 36 | Percentage of participants with transformation to AP and BP at Month 36. Transformation to AP or to BP CML defined as the time from first dose to the first date of transformation to accelerated phase or to blast phase CML. Documented participants who did not progress to AP or BP were censored at the last hematologic assessment. The transformation to AP or to BP was counted while participants were on treatment up to 28 days after last dose. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event. |
| Secondary | Number of Participants With BCR-ABL Mutation at Treatment Discontinuation | Maximum up to 44 months of treatment | Mutation analysis was performed in case of either lack of response, suboptimal response or loss of response, or at the End of Treatment/Withdrawal visit. |
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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