TriangleNCT00261846 · OUTCOME
Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % probability of retaining MCyR
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5
What was measured
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. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.
Analysis population: Subgroup of participants from evaluable population who had MCyR.
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.
| Group | Source count |
|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 107 |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 67.2 | Not reported | 56.8 | 75.6 | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 79.8 | Not reported | 63.1 | 89.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.8
- upper Limit
- 75.6
- value
- 67.2
- group Id
- OG001
- lower Limit
- 63.1
- upper Limit
- 89.5
- value
- 79.8
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- 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. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.
- 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)
- param Type
- NUMBER
- population Description
- Subgroup of participants from evaluable population who had MCyR.
- reporting Status
- POSTED
- time Frame
- From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5
- title
- Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2
- type
- SECONDARY
- unit Of Measure
- % probability of retaining MCyR
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice