TriangleNCT00261846 · OUTCOME
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Post-therapy
What was measured
Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of \<40 beats per min and value \>150 beats per min, SBP of \<80 or \>210 mmHg, DBP of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, Resp of \<10 or \>50 breaths/min and criteria for PCI change in physical examination: \>=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
Analysis population: Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.
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 | Source count |
|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 24 |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 16 |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 1 |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 2 |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 11 |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 4 |
| AP-CML Total (Part 2) | 8 |
| BP-CML Total (Part 2) | 3 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 0 |
Reported measurements
Pulse <40 bpm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 4.2 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 0 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
SBP >210 mmHg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 0 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 12.5 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
Weight increase 10%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 4.2 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 0 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 33.3 | Not reported | Not reported | Not reported | Not reported |
Weight decrease 10%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 12.5 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 6.7 | 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) | 9.1 | 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) | 16.7 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Pulse <40 bpm
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 12.5
- group Id
- OG007
- value
- 0
- title
- SBP >210 mmHg
- categories
- measurements
- group Id
- OG000
- value
- 4.2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 33.3
- title
- Weight increase 10%
- categories
- measurements
- group Id
- OG000
- value
- 12.5
- group Id
- OG001
- value
- 6.7
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 9.1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 16.7
- group Id
- OG007
- value
- 0
- title
- Weight decrease 10%
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- description
- Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of \<40 beats per min and value \>150 beats per min, SBP of \<80 or \>210 mmHg, DBP of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, Resp of \<10 or \>50 breaths/min and criteria for PCI change in physical examination: \>=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
- 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. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.
- reporting Status
- POSTED
- time Frame
- Post-therapy
- title
- Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice