TriangleNCT00261846 · OUTCOME
Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
What was measured
The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.
Analysis population: Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.
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 | Source count |
|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 169 |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 76 |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 4 |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 26 |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 37 |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 19 |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 17 |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 7 |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 9 |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 1 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 2.0 | Not reported | 1.1 | 2.1 | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 1.3 | Not reported | 1.1 | 2.1 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 1.6 | Not reported | 1.1 | 2.1 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 1.2 | Not reported | 1.1 | 3.0 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 1.3 | Not reported | 1.1 | 2.3 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 2.4 | Not reported | 1.1 | 3.3 | Not reported |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 12.1 | Not reported | 8.1 | 24.0 | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 12.1 | Not reported | 4.3 | 72.0 | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 8.0 | Not reported | 4.0 | 13.0 | Not reported |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 12.1 | Not reported | NA | NA | 95% CIs were NA due to insufficient patients and/or follow-up. |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 10.0 | Not reported | 4.0 | 13.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 2.1
- value
- 2.0
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 2.1
- value
- 1.3
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 2.1
- value
- 1.6
- group Id
- OG003
- lower Limit
- 1.1
- upper Limit
- 3.0
- value
- 1.2
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- 2.3
- value
- 1.3
- group Id
- OG005
- lower Limit
- 1.1
- upper Limit
- 3.3
- value
- 2.4
- group Id
- OG006
- lower Limit
- 8.1
- upper Limit
- 24.0
- value
- 12.1
- group Id
- OG007
- lower Limit
- 4.3
- upper Limit
- 72.0
- value
- 12.1
- group Id
- OG008
- lower Limit
- 4.0
- upper Limit
- 13.0
- value
- 8.0
- comment
- 95% CIs were NA due to insufficient patients and/or follow-up.
- group Id
- OG009
- lower Limit
- NA
- upper Limit
- NA
- value
- 12.1
- group Id
- OG010
- lower Limit
- 4.0
- upper Limit
- 13.0
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 76
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 37
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 2
- units
- Participants
- description
- The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.
- dispersion Type
- 95% Confidence Interval
- 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
- 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)
- 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)
- 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)
- 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)
- 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
- MEDIAN
- population Description
- Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.
- reporting Status
- POSTED
- time Frame
- Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
- title
- Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice