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NCT00261846 · OUTCOME

Duration of Potentially Clinically Important (PCI) 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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Baseline up to follow-up visit (30 days after last dose of study treatment)

What was measured

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates. NA = not estimable.

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

Anaemia
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)14.0Not reported11373Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)36.0Not reported2688Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)38.0Not reported3838Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)19.0Not reported1284Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)13.0Not reported6271Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)61.0Not reported6335Not reported
AP-CML Total (Part 2)12.5Not reported1502Not reported
BP-CML Total (Part 2)4.0Not reported152Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)7.0Not reported120Not reported
ALT
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)29.0Not reported1775Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)15.0Not reported1344Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)21.5Not reported7236Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)8.0Not reported587Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)21.0Not reported442Not reported
AP-CML Total (Part 2)21.5Not reported7252Not reported
BP-CML Total (Part 2)7.5Not reported141Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3.0Not reported15Not reported
AST
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)29.0Not reported1803Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)13.5Not reported1330Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)18.0Not reported1422Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)8.5Not reported822Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)15.0Not reported821Not reported
AP-CML Total (Part 2)14.0Not reported1188Not reported
BP-CML Total (Part 2)2.0Not reported22Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)5.0Not reported55Not reported
Diarrhoea
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reported12174Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2.0Not reported11121Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)2.0Not reported159Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.0Not reported1189Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reported1413Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)1.0Not reported1289Not reported
AP-CML Total (Part 2)2.0Not reported1910Not reported
BP-CML Total (Part 2)2.0Not reported1211Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3.0Not reported1500Not reported
Effusion
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)18.5Not reported11428Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)29.0Not reported5657Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)79.5Not reported14421Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)20.0Not reported7842Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)28.0Not reported1907Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)20.0Not reported5258Not reported
AP-CML Total (Part 2)21.0Not reported41536Not reported
BP-CML Total (Part 2)58.0Not reported11101Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)5.0Not reported425Not reported
Infection
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)10.0Not reported11026Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)9.5Not reported1546Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)11.5Not reported146Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)8.0Not reported185Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)9.0Not reported2366Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)8.0Not reported1183Not reported
AP-CML Total (Part 2)9.0Not reported1281Not reported
BP-CML Total (Part 2)9.5Not reported178Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)9.0Not reported139Not reported
Nausea
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)2.0Not reported1972Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)4.0Not reported1446Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)4.0Not reported17Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.0Not reported1168Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)14.0Not reported1713Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)2.0Not reported142Not reported
AP-CML Total (Part 2)6.0Not reported1247Not reported
BP-CML Total (Part 2)6.5Not reported1274Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)9.0Not reported131Not reported
Neutropenia
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)23.0Not reported1506Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)15.0Not reported1337Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)23.0Not reported1370Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)14.5Not reported481Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)21.0Not reported3504Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)26.0Not reported792Not reported
AP-CML Total (Part 2)8.0Not reported1252Not reported
BP-CML Total (Part 2)5.0Not reported152Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)6.5Not reported58Not reported
Oedema
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)29.0Not reported11416Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)81.5Not reported11807Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)4.0Not reported152Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)1.0Not reported1455Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)12.5Not reported2774Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)28.0Not reported3316Not reported
AP-CML Total (Part 2)88.5Not reported2670Not reported
BP-CML Total (Part 2)11.0Not reported1214Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)5.0Not reported18Not reported
Rash
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)15.0Not reported11622Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)13.0Not reported1965Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)17.0Not reported752Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)12.0Not reported1348Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)19.0Not reported11612Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)12.5Not reported1150Not reported
AP-CML Total (Part 2)13.0Not reported1428Not reported
BP-CML Total (Part 2)7.5Not reported1218Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)12.0Not reported133Not reported
Renal events
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)27.0Not reported1831Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)190.0Not reported7903Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)1167.0Not reported11671167Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)162.0Not reported21299Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)11.0Not reported1203Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)56.5Not reported2984Not reported
AP-CML Total (Part 2)26.0Not reported31403Not reported
BP-CML Total (Part 2)9.0Not reported127Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)12.0Not reported1212Not reported
Thrombocytopenia
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)22.0Not reported11762Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)15.0Not reported11541Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)38.5Not reported14120Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)15.0Not reported1336Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)15.0Not reported2420Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)21.5Not reported6350Not reported
AP-CML Total (Part 2)11.5Not reported1889Not reported
BP-CML Total (Part 2)5.0Not reported1176Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)9.0Not reported343Not reported
Vomiting
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reported1165Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.0Not reported136Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)1.0Not reported1141Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reported159Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)7.0Not reported139Not reported
AP-CML Total (Part 2)1.0Not reported1128Not reported
BP-CML Total (Part 2)1.0Not reported141Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1.5Not reported19Not reported
Cardiac events
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)11.0Not reported11428Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)6.0Not reported1657Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7.5Not reported1842Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)22.0Not reported1907Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)1.0Not reported11Not reported
AP-CML Total (Part 2)14.0Not reported11536Not reported
BP-CML Total (Part 2)3.0Not reported119Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1.5Not reported12Not reported
Vascular events
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)3.5Not reported1277Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)6.0Not reported159Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)10.5Not reported318Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1.5Not reported1266Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)10.0Not reported1010Not reported
AP-CML Total (Part 2)2.0Not reported122Not reported
BP-CML Total (Part 2)1.0Not reported114Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)1.0Not reported119Not reported
Hypertension
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)16.0Not reported11343Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)1.0Not reported11659Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7.0Not reported77Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)1.0Not reported1418Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)NANot reportedNANANo events therefore duration not available.
AP-CML Total (Part 2)5.0Not reported1204Not reported
BP-CML Total (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, Ph+ ALL (Part 2)2.0Not reported22Not reported
Gastrointestinal events
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)1.0Not reported12174Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)2.0Not reported11121Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)2.0Not reported159Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)2.0Not reported1189Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)2.0Not reported1713Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)2.0Not reported1289Not reported
AP-CML Total (Part 2)2.0Not reported1910Not reported
BP-CML Total (Part 2)3.0Not reported1274Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)4.0Not reported1500Not reported
Haemorrhage
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)10.0Not reported1862Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)16.0Not reported1131Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)23.0Not reported2323Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)4.0Not reported111Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)27.5Not reported1190Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)7.5Not reported158Not reported
AP-CML Total (Part 2)6.0Not reported1147Not reported
BP-CML Total (Part 2)4.0Not reported128Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)3.5Not reported121Not reported
Hypersensitivity
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)9.0Not reported638Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)8.0Not reported79Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)7.0Not reported128Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)6.0Not reported115Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)5.0Not reported19Not reported
AP-CML Total (Part 2)1.0Not reported11Not reported
BP-CML Total (Part 2)NANot reportedNANANo events therefore duration not available.
Bosutinib 500 mg, Ph+ ALL (Part 2)NANot reportedNANANo events therefore duration not available.
Liver
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)29.0Not reported1803Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)16.0Not reported1344Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)8.0Not reported88Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)25.5Not reported7236Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)9.0Not reported5136Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)21.0Not reported382Not reported
AP-CML Total (Part 2)16.0Not reported1252Not reported
BP-CML Total (Part 2)8.0Not reported1441Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)5.0Not reported19Not reported
Myelosuppression
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)22.0Not reported11762Not reported
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)18.0Not reported11541Not reported
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)28.0Not reported13120Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)15.0Not reported1336Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)15.0Not reported2504Not reported
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)27.0Not reported6769Not reported
AP-CML Total (Part 2)11.5Not reported1889Not reported
BP-CML Total (Part 2)5.0Not reported1376Not reported
Bosutinib 500 mg, Ph+ ALL (Part 2)7.0Not reported143Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1373
        value
        14.0
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        688
        value
        36.0
      3. group Id
        OG002
        lower Limit
        38
        upper Limit
        38
        value
        38.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        284
        value
        19.0
      5. group Id
        OG004
        lower Limit
        6
        upper Limit
        271
        value
        13.0
      6. group Id
        OG005
        lower Limit
        6
        upper Limit
        335
        value
        61.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        502
        value
        12.5
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        52
        value
        4.0
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        20
        value
        7.0
    title
    Anaemia
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        775
        value
        29.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        344
        value
        15.0
      3. comment
        No events therefore duration not available.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. group Id
        OG003
        lower Limit
        7
        upper Limit
        236
        value
        21.5
      5. group Id
        OG004
        lower Limit
        5
        upper Limit
        87
        value
        8.0
      6. group Id
        OG005
        lower Limit
        4
        upper Limit
        42
        value
        21.0
      7. group Id
        OG006
        lower Limit
        7
        upper Limit
        252
        value
        21.5
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        41
        value
        7.5
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        5
        value
        3.0
    title
    ALT
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        803
        value
        29.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        330
        value
        13.5
      3. comment
        No events therefore duration not available.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. group Id
        OG003
        lower Limit
        14
        upper Limit
        22
        value
        18.0
      5. group Id
        OG004
        lower Limit
        8
        upper Limit
        22
        value
        8.5
      6. group Id
        OG005
        lower Limit
        8
        upper Limit
        21
        value
        15.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        188
        value
        14.0
      8. group Id
        OG007
        lower Limit
        2
        upper Limit
        2
        value
        2.0
      9. group Id
        OG008
        lower Limit
        5
        upper Limit
        5
        value
        5.0
    title
    AST
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        2174
        value
        1.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        1121
        value
        2.0
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        59
        value
        2.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        189
        value
        2.0
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        413
        value
        2.0
      6. group Id
        OG005
        lower Limit
        1
        upper Limit
        289
        value
        1.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        910
        value
        2.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        211
        value
        2.0
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        500
        value
        3.0
    title
    Diarrhoea
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1428
        value
        18.5
      2. group Id
        OG001
        lower Limit
        5
        upper Limit
        657
        value
        29.0
      3. group Id
        OG002
        lower Limit
        14
        upper Limit
        421
        value
        79.5
      4. group Id
        OG003
        lower Limit
        7
        upper Limit
        842
        value
        20.0
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        907
        value
        28.0
      6. group Id
        OG005
        lower Limit
        5
        upper Limit
        258
        value
        20.0
      7. group Id
        OG006
        lower Limit
        4
        upper Limit
        1536
        value
        21.0
      8. group Id
        OG007
        lower Limit
        11
        upper Limit
        101
        value
        58.0
      9. group Id
        OG008
        lower Limit
        4
        upper Limit
        25
        value
        5.0
    title
    Effusion
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1026
        value
        10.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        546
        value
        9.5
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        46
        value
        11.5
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        85
        value
        8.0
      5. group Id
        OG004
        lower Limit
        2
        upper Limit
        366
        value
        9.0
      6. group Id
        OG005
        lower Limit
        1
        upper Limit
        183
        value
        8.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        281
        value
        9.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        78
        value
        9.5
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        39
        value
        9.0
    title
    Infection
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        972
        value
        2.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        446
        value
        4.0
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        7
        value
        4.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        168
        value
        2.0
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        713
        value
        14.0
      6. group Id
        OG005
        lower Limit
        1
        upper Limit
        42
        value
        2.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        247
        value
        6.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        274
        value
        6.5
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        31
        value
        9.0
    title
    Nausea
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        506
        value
        23.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        337
        value
        15.0
      3. group Id
        OG002
        lower Limit
        13
        upper Limit
        70
        value
        23.0
      4. group Id
        OG003
        lower Limit
        4
        upper Limit
        81
        value
        14.5
      5. group Id
        OG004
        lower Limit
        3
        upper Limit
        504
        value
        21.0
      6. group Id
        OG005
        lower Limit
        7
        upper Limit
        92
        value
        26.0
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        252
        value
        8.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        52
        value
        5.0
      9. group Id
        OG008
        lower Limit
        5
        upper Limit
        8
        value
        6.5
    title
    Neutropenia
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1416
        value
        29.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        1807
        value
        81.5
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        52
        value
        4.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        455
        value
        1.0
      5. group Id
        OG004
        lower Limit
        2
        upper Limit
        774
        value
        12.5
      6. group Id
        OG005
        lower Limit
        3
        upper Limit
        316
        value
        28.0
      7. group Id
        OG006
        lower Limit
        2
        upper Limit
        670
        value
        88.5
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        214
        value
        11.0
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        8
        value
        5.0
    title
    Oedema
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1622
        value
        15.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        965
        value
        13.0
      3. group Id
        OG002
        lower Limit
        7
        upper Limit
        52
        value
        17.0
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        348
        value
        12.0
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        1612
        value
        19.0
      6. group Id
        OG005
        lower Limit
        1
        upper Limit
        150
        value
        12.5
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        428
        value
        13.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        218
        value
        7.5
      9. group Id
        OG008
        lower Limit
        1
        upper Limit
        33
        value
        12.0
    title
    Rash
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        831
        value
        27.0
      2. group Id
        OG001
        lower Limit
        7
        upper Limit
        903
        value
        190.0
      3. group Id
        OG002
        lower Limit
        1167
        upper Limit
        1167
        value
        1167.0
      4. group Id
        OG003
        lower Limit
        21
        upper Limit
        299
        value
        162.0
      5. group Id
        OG004
        lower Limit
        1
        upper Limit
        203
        value
        11.0
      6. group Id
        OG005
        lower Limit
        29
        upper Limit
        84
        value
        56.5
      7. group Id
        OG006
        lower Limit
        3
        upper Limit
        1403
        value
        26.0
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        27
        value
        9.0
      9. group Id
        OG008
        lower Limit
        12
        upper Limit
        12
        value
        12.0
    title
    Renal events
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        1762
        value
        22.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        1541
        value
        15.0
      3. group Id
        OG002
        lower Limit
        14
        upper Limit
        120
        value
        38.5
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        336
        value
        15.0
      5. group Id
        OG004
        lower Limit
        2
        upper Limit
        420
        value
        15.0
      6. group Id
        OG005
        lower Limit
        6
        upper Limit
        350
        value
        21.5
      7. group Id
        OG006
        lower Limit
        1
        upper Limit
        889
        value
        11.5
      8. group Id
        OG007
        lower Limit
        1
        upper Limit
        176
        value
        5.0
      9. group Id
        OG008
        lower Limit
        3
        upper Limit
        43
        value
        9.0
    title
    Thrombocytopenia
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
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates. NA = not estimable.
dispersion Type
Full Range
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
MEDIAN
population Description
Safety population included all participants who receive at least one dose of study medication.
reporting Status
POSTED
time Frame
Baseline up to follow-up visit (30 days after last dose of study treatment)
title
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
type
SECONDARY
unit Of Measure
days

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