TriangleNCT00261846 · OUTCOME
Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2
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
- 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
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count ≥ 1.0×10\^9/L , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).
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.
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) | 194 |
| 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) | 49 |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 25 |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 43 |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 29 |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 34 |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 26 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 87.1 | Not reported | 81.6 | 91.5 | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 85.4 | Not reported | 76.3 | 92.0 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 80.0 | Not reported | 28.4 | 99.5 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 68.4 | Not reported | 51.3 | 82.5 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 75.5 | Not reported | 61.1 | 86.7 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 76.0 | Not reported | 54.9 | 90.6 | Not reported |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 39.5 | Not reported | 25.0 | 55.6 | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 26.5 | Not reported | 12.9 | 44.4 | Not reported |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 3.8 | Not reported | 0.1 | 19.6 | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 9.1 | Not reported | 1.1 | 29.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.6
- upper Limit
- 91.5
- value
- 87.1
- group Id
- OG001
- lower Limit
- 76.3
- upper Limit
- 92.0
- value
- 85.4
- group Id
- OG002
- lower Limit
- 28.4
- upper Limit
- 99.5
- value
- 80.0
- group Id
- OG003
- lower Limit
- 51.3
- upper Limit
- 82.5
- value
- 68.4
- group Id
- OG004
- lower Limit
- 61.1
- upper Limit
- 86.7
- value
- 75.5
- group Id
- OG005
- lower Limit
- 54.9
- upper Limit
- 90.6
- value
- 76.0
- group Id
- OG006
- lower Limit
- 25.0
- upper Limit
- 55.6
- value
- 39.5
- group Id
- OG007
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- group Id
- OG008
- lower Limit
- 12.9
- upper Limit
- 44.4
- value
- 26.5
- group Id
- OG009
- lower Limit
- 0.1
- upper Limit
- 19.6
- value
- 3.8
- group Id
- OG010
- lower Limit
- 1.1
- upper Limit
- 29.2
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 194
- group Id
- OG001
- value
- 89
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 49
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 43
- group Id
- OG007
- value
- 29
- group Id
- OG008
- value
- 34
- group Id
- OG009
- value
- 26
- group Id
- OG010
- value
- 22
- units
- Participants
- description
- Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count ≥ 1.0×10\^9/L , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).
- 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
- Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.
- 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
- Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice