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NCT00261846 · OUTCOME

Percentage of Participants With Change From Baseline in Laboratory Tests Results

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias · Source last updated 2017-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter

What was measured

Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.

Analysis population: Safety population included all participants who receive at least one dose of study medication.

Groups in this outcome

Bosutinib 500 mg, CP2L-CML IM-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, CP2L-CML IM-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.

Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.

Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.

Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.

AP-CML Total (Part 2)

All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.

BP-CML Total (Part 2)

All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.

Bosutinib 500 mg, Ph+ ALL (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)195
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)89
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)5
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)38
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)50
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)26
AP-CML Total (Part 2)79
BP-CML Total (Part 2)64
Bosutinib 500 mg, Ph+ ALL (Part 2)24

Reported measurements

Hemoglobin: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)3.8Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)5.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)1.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Normal to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)10.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)7.6Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)6.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Grade 1 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)4.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)1.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Grade 2 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)6.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7.9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)10.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)15.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)16.7Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Grade 2 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)2.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)4.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)2.5Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.2Not reportedNot reportedNot reportedNot reported
Hemoglobin: shift from Grade 3 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)5.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Absolute neutrophils (ANC): Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)7.2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)9.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)5.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)4.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)11.5Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)10.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ANC: shift from Normal to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)2.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)3.4Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)20.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7.9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)4.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)3.8Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)2.5Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ANC: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2.2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)2.5Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)7.8Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)12.5Not reportedNot reportedNot reportedNot reported
ANC: shift from Grade 1 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)1.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)20.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.2Not reportedNot reportedNot reportedNot reported
ANC: shift from Grade 2 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)3.4Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)3.8Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ANC: shift from Grade 2 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)1.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reportedNot reportedNot reportedNot reported
ANC: shift from Grade 3 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)8.3Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)13.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)13.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)15.8Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)12.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)7.7Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)11.4Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.2Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Normal to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)7.9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)8.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)15.4Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)7.6Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)1.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)5.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)3.8Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)5.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)3.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.2Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Grade 1 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)4.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)6.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)6.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Grade 2 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2.2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)20.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)3.8Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Grade 2 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)1.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)4.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Platelet count: shift from Grade 3 to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)5.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)10.9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)29.2Not reportedNot reportedNot reportedNot reported
ALT: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)8.7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)12.4Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)10.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)15.4Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)5.1Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)1.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ALT: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)3.8Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AST: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)4.1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)7.9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)7.7Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)2.5Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)1.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AST: shift from Normal to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)3.8Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AST: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)2.5Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ALP: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)1.3Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
ALP: shift from Grade 1 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)1.6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Total bilirubin: shift from Normal to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)6.3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.2Not reportedNot reportedNot reportedNot reported
ALT: shift from Normal to Grade 4
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2.2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)3.8Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Total bilirubin: shift from Grade 2 to Grade 3
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0.0Not reportedNot reportedNot reportedNot reported
AP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
BP-CML Total (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        1.1
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        3.8
      7. group Id
        OG006
        value
        5.1
      8. group Id
        OG007
        value
        1.6
      9. group Id
        OG008
        value
        0.0
    title
    Hemoglobin: shift from Normal to Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        0.0
      8. group Id
        OG007
        value
        0.0
      9. group Id
        OG008
        value
        0.0
    title
    Hemoglobin: shift from Normal to Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3.6
      2. group Id
        OG001
        value
        10.1
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.6
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        7.6
      8. group Id
        OG007
        value
        6.3
      9. group Id
        OG008
        value
        8.3
    title
    Hemoglobin: shift from Grade 1 to Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        4.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        1.3
      8. group Id
        OG007
        value
        3.1
      9. group Id
        OG008
        value
        0.0
    title
    Hemoglobin: shift from Grade 1 to Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3.1
      2. group Id
        OG001
        value
        6.7
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        7.9
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        10.1
      8. group Id
        OG007
        value
        15.6
      9. group Id
        OG008
        value
        16.7
    title
    Hemoglobin: shift from Grade 2 to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
      2. group Id
        OG001
        value
        1.1
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        4.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        2.5
      8. group Id
        OG007
        value
        4.7
      9. group Id
        OG008
        value
        4.2
    title
    Hemoglobin: shift from Grade 2 to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        5.1
      8. group Id
        OG007
        value
        4.7
      9. group Id
        OG008
        value
        0.0
    title
    Hemoglobin: shift from Grade 3 to Grade 4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        7.2
      2. group Id
        OG001
        value
        9.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        5.3
      5. group Id
        OG004
        value
        4.0
      6. group Id
        OG005
        value
        11.5
      7. group Id
        OG006
        value
        10.1
      8. group Id
        OG007
        value
        3.1
      9. group Id
        OG008
        value
        0.0
    title
    Absolute neutrophils (ANC): Normal to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
      2. group Id
        OG001
        value
        3.4
      3. group Id
        OG002
        value
        20.0
      4. group Id
        OG003
        value
        7.9
      5. group Id
        OG004
        value
        4.0
      6. group Id
        OG005
        value
        3.8
      7. group Id
        OG006
        value
        2.5
      8. group Id
        OG007
        value
        3.1
      9. group Id
        OG008
        value
        0.0
    title
    ANC: shift from Normal to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        2.2
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        2.5
      8. group Id
        OG007
        value
        7.8
      9. group Id
        OG008
        value
        12.5
    title
    ANC: shift from Grade 1 to Grade 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.6
      5. group Id
        OG004
        value
        2.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        1.3
      8. group Id
        OG007
        value
        20.3
      9. group Id
        OG008
        value
        4.2
    title
    ANC: shift from Grade 1 to Grade 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1.0
      2. group Id
        OG001
        value
        3.4
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        2.6
      5. group Id
        OG004
        value
        2.0
      6. group Id
        OG005
        value
        0.0
      7. group Id
        OG006
        value
        3.8
      8. group Id
        OG007
        value
        0.0
      9. group Id
        OG008
        value
        0.0
    title
    ANC: shift from Grade 2 to Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      89
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      38
    5. group Id
      OG004
      value
      50
    6. group Id
      OG005
      value
      26
    7. group Id
      OG006
      value
      79
    8. group Id
      OG007
      value
      64
    9. group Id
      OG008
      value
      24
    units
    Participants
description
Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.
groups
  1. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG000
    title
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
  2. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG001
    title
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
  3. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
    id
    OG002
    title
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
  4. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
    id
    OG003
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
  5. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
    id
    OG004
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
  6. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
    id
    OG005
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
    id
    OG006
    title
    AP-CML Total (Part 2)
  8. description
    All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
    id
    OG007
    title
    BP-CML Total (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    OG008
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
param Type
NUMBER
population Description
Safety population included all participants who receive at least one dose of study medication.
reporting Status
POSTED
time Frame
Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter
title
Percentage of Participants With Change From Baseline in Laboratory Tests Results
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice