Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00261846 · OUTCOME

Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

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
participants
Interval / dispersion
Not reported
Time frame
Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter

What was measured

ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair \>50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.

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.

Bosutinib 500 mg, AP-CML IM R/I (Part 2)

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

Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)

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

Bosutinib 500 mg, BP-CML IM R/I (Part 2)

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

Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)

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

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
Bosutinib 500 mg, AP-CML IM R/I (Part 2)49
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)30
Bosutinib 500 mg, BP-CML IM R/I (Part 2)36
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)28
Bosutinib 500 mg, Ph+ ALL (Part 2)24

Reported measurements

Baseline: Grade 0; maximum on-therapy: Grade 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)92Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)36Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)21Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)20Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)19Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)17Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)9Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)2Not reportedNot reportedNot reportedNot reported
Baseline: Grade 0; maximum on-therapy: Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)50Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)25Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)8Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)11Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)47Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4Not reportedNot reportedNot reportedNot reported
Baseline: Grade 0; maximum on-therapy: Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)2Not reportedNot reportedNot reportedNot reported
Baseline: Grade 0; maximum on-therapy: Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)4Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 0; maximum on-therapy: Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Grade 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)32Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)13Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)13Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)14Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)7Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)10Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)5Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 2; maximum on-therapy: Grade 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 2; maximum on-therapy: Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 2; maximum on-therapy: Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)6Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4Not reportedNot reportedNot reportedNot reported
Baseline: Grade 2; maximum on-therapy: Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)2Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 2; maximum on-therapy: Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1Not reportedNot reportedNot reportedNot reported
Baseline: Missing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)0Not reportedNot reportedNot reportedNot reported
Baseline: Grade 0; maximum on-therapy: Missing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1Not reportedNot reportedNot reportedNot reported
Baseline: Grade 1; maximum on-therapy: Missing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML IM R/I (Part 2)0Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)3Not reportedNot reportedNot reportedNot reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        21
      5. group Id
        OG004
        value
        20
      6. group Id
        OG005
        value
        19
      7. group Id
        OG006
        value
        17
      8. group Id
        OG007
        value
        9
      9. group Id
        OG008
        value
        9
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        2
    title
    Baseline: Grade 0; maximum on-therapy: Grade 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        47
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        4
    title
    Baseline: Grade 0; maximum on-therapy: Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        2
    title
    Baseline: Grade 0; maximum on-therapy: Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 0; maximum on-therapy: Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 0; maximum on-therapy: Grade 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
    title
    Baseline: Grade 1; maximum on-therapy: Grade 0
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        7
      9. group Id
        OG008
        value
        7
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        3
    title
    Baseline: Grade 1; maximum on-therapy: Grade 1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        6
      11. group Id
        OG010
        value
        3
    title
    Baseline: Grade 1; maximum on-therapy: Grade 2
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 1; maximum on-therapy: Grade 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 1; maximum on-therapy: Grade 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 2; maximum on-therapy: Grade 0
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
    title
    Baseline: Grade 2; maximum on-therapy: Grade 1
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
      49
    8. group Id
      OG007
      value
      30
    9. group Id
      OG008
      value
      36
    10. group Id
      OG009
      value
      28
    11. group Id
      OG010
      value
      24
    units
    Participants
description
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair \>50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.
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
    Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG006
    title
    Bosutinib 500 mg, AP-CML IM R/I (Part 2)
  8. description
    Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG007
    title
    Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG008
    title
    Bosutinib 500 mg, BP-CML IM R/I (Part 2)
  10. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG009
    title
    Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
  11. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    OG010
    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
Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter
title
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice