TriangleNCT00261846 · OUTCOME
Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia 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
- Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year
What was measured
OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, \<5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10\^9/L \> platelets \> 20x10\^9/L, absolute neutrophil count ≥0.5x10\^9/L, \<20% basophils in blood, no extramedullary involvement \[including liver or spleen\]), minor hematologic response (acute lymphoblastic leukemia \[ALL\] patients only, defined as \<15% blasts in marrow \& blood, \<30% blasts + promyelocytes in marrow \& blood, \<20% basophils in peripheral blood \& no extramedullary disease other than spleen \& liver) or return to chronic phase (AP/BP participants, defined as \<15% blasts in both peripheral blood \&bone marrow, \<30% blasts + promyelocytes in both peripheral blood \& bone marrow, \<20% basophils in both peripheral blood \& bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.
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, 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, 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, AP-CML IM R/I (Part 2) | 67.4 | Not reported | 51.5 | 80.9 | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 41.4 | Not reported | 23.5 | 61.1 | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 38.2 | Not reported | 22.2 | 56.4 | Not reported |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 15.4 | Not reported | 4.4 | 34.9 | 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
- 51.5
- upper Limit
- 80.9
- value
- 67.4
- group Id
- OG001
- lower Limit
- 23.5
- upper Limit
- 61.1
- value
- 41.4
- group Id
- OG002
- lower Limit
- 22.2
- upper Limit
- 56.4
- value
- 38.2
- group Id
- OG003
- lower Limit
- 4.4
- upper Limit
- 34.9
- value
- 15.4
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- 29.2
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 22
- units
- Participants
- description
- OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, \<5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10\^9/L \> platelets \> 20x10\^9/L, absolute neutrophil count ≥0.5x10\^9/L, \<20% basophils in blood, no extramedullary involvement \[including liver or spleen\]), minor hematologic response (acute lymphoblastic leukemia \[ALL\] patients only, defined as \<15% blasts in marrow \& blood, \<30% blasts + promyelocytes in marrow \& blood, \<20% basophils in peripheral blood \& no extramedullary disease other than spleen \& liver) or return to chronic phase (AP/BP participants, defined as \<15% blasts in both peripheral blood \&bone marrow, \<30% blasts + promyelocytes in both peripheral blood \& bone marrow, \<20% basophils in both peripheral blood \& bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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 1 year
- title
- Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice