TriangleNCT00261846 · OUTCOME
Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings
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
- Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit
What was measured
Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval \>=220 msec and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) \>500 msec or increase of \>60 msec; heart rate \<=45 beats per minute (bpm) or \>=120 bpm or decrease/increase of \>=15 bpm.
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.
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) | 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) | 37 |
| 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) | 78 |
| BP-CML Total (Part 2) | 62 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 32.3 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 23.6 | 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) | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 24.3 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 22.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 23.1 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 39.7 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 59.7 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 34.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32.3
- group Id
- OG001
- value
- 23.6
- group Id
- OG002
- value
- 20.0
- group Id
- OG003
- value
- 24.3
- group Id
- OG004
- value
- 22.0
- group Id
- OG005
- value
- 23.1
- group Id
- OG006
- value
- 39.7
- group Id
- OG007
- value
- 59.7
- group Id
- OG008
- value
- 34.8
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 89
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 37
- group Id
- OG004
- value
- 50
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 78
- group Id
- OG007
- value
- 62
- group Id
- OG008
- value
- 23
- units
- Participants
- description
- Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval \>=220 msec and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) \>500 msec or increase of \>60 msec; heart rate \<=45 beats per minute (bpm) or \>=120 bpm or decrease/increase of \>=15 bpm.
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit
- title
- Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice