NCT00261846 · OUTCOME

Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)

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 and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months

What was measured

Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE 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

Group	Source 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

ALT

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	7	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	1	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

AST

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	4	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	2	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Anemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	6	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	8	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	6	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	1	Not reported	Not reported	Not reported	Not reported

Cardiac events

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	13	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	6	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	7	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	1	Not reported	Not reported	Not reported	Not reported

Gastrointestinal toxicity - Diarrhoea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	120	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	46	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	22	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	26	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	14	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	44	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	22	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	10	Not reported	Not reported	Not reported	Not reported

Effusion

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	11	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	9	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	9	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Haemorrhage

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	12	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	4	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	6	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	3	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	15	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	7	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	2	Not reported	Not reported	Not reported	Not reported

Hypersensitivity reactions

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	1	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	92	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	39	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	11	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	18	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	10	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	37	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	30	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	7	Not reported	Not reported	Not reported	Not reported

Hepatic events

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	10	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	3	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal toxicity - Nausea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	33	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	25	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	11	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	10	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	8	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	19	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	23	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	7	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	1	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	6	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	2	Not reported	Not reported	Not reported	Not reported

Rash

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	44	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	37	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	8	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	16	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	3	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	20	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	9	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	2	Not reported	Not reported	Not reported	Not reported

Oedema

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	13	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	9	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	7	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	7	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	3	Not reported	Not reported	Not reported	Not reported

Renal

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	4	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	4	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	2	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	10	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	19	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	13	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	3	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Vascular events

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	6	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	3	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	0	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	2	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	1	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal toxicity - Vomiting

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)	25	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)	9	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)	0	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)	5	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)	7	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)	4	Not reported	Not reported	Not reported	Not reported
AP-CML Total (Part 2)	17	Not reported	Not reported	Not reported	Not reported
BP-CML Total (Part 2)	14	Not reported	Not reported	Not reported	Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
0
title
ALT
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
0
title
AST
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
1
group Id
OG006
value
6
group Id
OG007
value
1
group Id
OG008
value
1
title
Anemia
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
6
group Id
OG005
value
0
group Id
OG006
value
7
group Id
OG007
value
2
group Id
OG008
value
1
title
Cardiac events
categories
measurements
group Id
OG000
value
120
group Id
OG001
value
46
group Id
OG002
value
2
group Id
OG003
value
22
group Id
OG004
value
26
group Id
OG005
value
14
group Id
OG006
value
44
group Id
OG007
value
22
group Id
OG008
value
10
title
Gastrointestinal toxicity - Diarrhoea
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
5
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
9
group Id
OG005
value
1
group Id
OG006
value
9
group Id
OG007
value
2
group Id
OG008
value
0
title
Effusion
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
4
group Id
OG007
value
6
group Id
OG008
value
3
title
Haemorrhage
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
1
group Id
OG006
value
7
group Id
OG007
value
2
group Id
OG008
value
2
title
Hypertension
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
1
group Id
OG008
value
0
title
Hypersensitivity reactions
categories
measurements
group Id
OG000
value
92
group Id
OG001
value
39
group Id
OG002
value
4
group Id
OG003
value
11
group Id
OG004
value
18
group Id
OG005
value
10
group Id
OG006
value
37
group Id
OG007
value
30
group Id
OG008
value
7
title
Infection
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
0
title
Hepatic events
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
25
group Id
OG002
value
1
group Id
OG003
value
11
group Id
OG004
value
10
group Id
OG005
value
8
group Id
OG006
value
19
group Id
OG007
value
23
group Id
OG008
value
7
title
Gastrointestinal toxicity - Nausea

denoms

counts
group Id
OG000
value
195
group Id
OG001
value
89
group Id
OG002
value
5
group Id
OG003
value
38
group Id
OG004
value
50
group Id
OG005
value
26
group Id
OG006
value
79
group Id
OG007
value
64
group Id
OG008
value
24
units
Participants

description

Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.

groups

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)
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)
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)
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)
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)
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)
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)
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)
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

Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months

title

Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice