TriangleNCT00261846 · OUTCOME
Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % estimate of maintaining response
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of first confirmed CHR to loss of CHR or censoring, assessed at 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
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets ≥100×10\^9/L \& \<450×10\^9/L, \<20% basophils in blood \& no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only \& applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L \& ADV: Year 4). NA = not estimable. NA = not estimable.
Analysis population: Subgroup of participants from evaluable population who had confirmed CHR.
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) | 61.5 | Not reported | 52.9 | 69.1 | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 78.2 | Not reported | 64.4 | 87.1 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 50.0 | Not reported | 5.8 | 84.5 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 56.5 | Not reported | 30.9 | 75.8 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 69.9 | Not reported | 49.7 | 83.3 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 61.9 | Not reported | 33.6 | 81.0 | Not reported |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 47.1 | Not reported | 20.7 | 69.7 | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 64.3 | Not reported | 15.1 | 90.2 | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | NA | Not reported | NA | NA | KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up. |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | NA | Not reported | NA | NA | KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up. |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 100 | Not reported | NA | 100 | Lower limit of the 95% CI was NA due to insufficient patients and/or follow-up. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.9
- upper Limit
- 69.1
- value
- 61.5
- group Id
- OG001
- lower Limit
- 64.4
- upper Limit
- 87.1
- value
- 78.2
- group Id
- OG002
- lower Limit
- 5.8
- upper Limit
- 84.5
- value
- 50.0
- group Id
- OG003
- lower Limit
- 30.9
- upper Limit
- 75.8
- value
- 56.5
- group Id
- OG004
- lower Limit
- 49.7
- upper Limit
- 83.3
- value
- 69.9
- group Id
- OG005
- lower Limit
- 33.6
- upper Limit
- 81.0
- value
- 61.9
- group Id
- OG006
- lower Limit
- 20.7
- upper Limit
- 69.7
- value
- 47.1
- group Id
- OG007
- lower Limit
- 15.1
- upper Limit
- 90.2
- value
- 64.3
- comment
- KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
- group Id
- OG009
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Lower limit of the 95% CI was NA due to insufficient patients and/or follow-up.
- group Id
- OG010
- lower Limit
- NA
- upper Limit
- 100
- value
- 100
- 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
- Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets ≥100×10\^9/L \& \<450×10\^9/L, \<20% basophils in blood \& no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only \& applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L \& ADV: Year 4). NA = not estimable. NA = not estimable.
- 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
- NUMBER
- population Description
- Subgroup of participants from evaluable population who had confirmed CHR.
- reporting Status
- POSTED
- time Frame
- From date of first confirmed CHR to loss of CHR or censoring, assessed at 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
- Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2
- type
- SECONDARY
- unit Of Measure
- % estimate of maintaining response
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Preserved source evidence · Not medical advice