TriangleNCT00261846 · OUTCOME
Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - 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
- Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)
What was measured
CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.
Analysis population: Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.
Groups in this outcome
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, 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.
| Group | Source count |
|---|---|
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 80 |
| 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) | 36 |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 45 |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 26 |
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 182 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 61.3 | Not reported | 49.7 | 71.9 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 38.9 | Not reported | 23.1 | 56.5 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 42.2 | Not reported | 27.7 | 57.9 | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 38.5 | Not reported | 20.2 | 59.4 | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 58.8 | Not reported | 51.3 | 66.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.7
- upper Limit
- 71.9
- value
- 61.3
- group Id
- OG001
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- group Id
- OG002
- lower Limit
- 23.1
- upper Limit
- 56.5
- value
- 38.9
- group Id
- OG003
- lower Limit
- 27.7
- upper Limit
- 57.9
- value
- 42.2
- group Id
- OG004
- lower Limit
- 20.2
- upper Limit
- 59.4
- value
- 38.5
- group Id
- OG005
- lower Limit
- 51.3
- upper Limit
- 66.0
- value
- 58.8
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 45
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 182
- units
- Participants
- description
- CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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 CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
- id
- OG005
- title
- Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
- param Type
- NUMBER
- population Description
- Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.
- reporting Status
- POSTED
- time Frame
- Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)
- title
- Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice