TriangleNCT00261846 · OUTCOME
Number of Participants With Change From Baseline in Findings of Chest X-ray
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Week 8, and end of treatment
What was measured
Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.
Analysis population: Safety population included all participants who received at lease one dose of study medication.
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.
AP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
BP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
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) | 195 |
| 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) | 50 |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 26 |
| AP-CML Total (Part 2) | 79 |
| BP-CML Total (Part 2) | 64 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 24 |
Reported measurements
Worsened From Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 35 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 18 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 18 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 16 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 3 | Not reported | Not reported | Not reported | Not reported |
Improved From Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 15 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 7 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 4 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 11 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 1 | Not reported | Not reported | Not reported | Not reported |
Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 50 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 25 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 19 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| AP-CML Total (Part 2) | 22 | Not reported | Not reported | Not reported | Not reported |
| BP-CML Total (Part 2) | 21 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 3
- title
- Worsened From Baseline
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 1
- title
- Improved From Baseline
- categories
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 22
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 4
- title
- Total
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 89
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 50
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 79
- group Id
- OG007
- value
- 64
- group Id
- OG008
- value
- 24
- units
- Participants
- description
- Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.
- 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
- All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
- id
- OG006
- title
- AP-CML Total (Part 2)
- description
- All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
- id
- OG007
- title
- BP-CML Total (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
- id
- OG008
- title
- Bosutinib 500 mg, Ph+ ALL (Part 2)
- param Type
- NUMBER
- population Description
- Safety population included all participants who received at lease one dose of study medication.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 8, and end of treatment
- title
- Number of Participants With Change From Baseline in Findings of Chest X-ray
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice