TriangleNCT00261846 · OUTCOME
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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
- Not reported
- Time frame
- Baseline up to follow up visit (30 days after last dose of study treatment)
What was measured
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Analysis population: Safety population included all participants who receive at least 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.
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) | 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 |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 49 |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 30 |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 36 |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 28 |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 24 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 99.5 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 100.0 | 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) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 97.2 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 95.8 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 500 mg, CP2L-CML IM-R (Part 2) | 41.5 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP2L-CML IM-I (Part 2) | 38.2 | 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) | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) | 39.5 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) | 38.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) | 19.2 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, AP-CML IM R/I (Part 2) | 49.0 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) | 63.3 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, BP-CML IM R/I (Part 2) | 55.6 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) | 60.7 | Not reported | Not reported | Not reported | Not reported |
| Bosutinib 500 mg, Ph+ ALL (Part 2) | 70.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.5
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- group Id
- OG004
- value
- 100.0
- group Id
- OG005
- value
- 100.0
- group Id
- OG006
- value
- 100.0
- group Id
- OG007
- value
- 100.0
- group Id
- OG008
- value
- 97.2
- group Id
- OG009
- value
- 100.0
- group Id
- OG010
- value
- 95.8
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 41.5
- group Id
- OG001
- value
- 38.2
- group Id
- OG002
- value
- 20.0
- group Id
- OG003
- value
- 39.5
- group Id
- OG004
- value
- 38.0
- group Id
- OG005
- value
- 19.2
- group Id
- OG006
- value
- 49.0
- group Id
- OG007
- value
- 63.3
- group Id
- OG008
- value
- 55.6
- group Id
- OG009
- value
- 60.7
- group Id
- OG010
- value
- 70.8
- title
- SAEs
- 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
- 49
- group Id
- OG007
- value
- 30
- group Id
- OG008
- value
- 36
- group Id
- OG009
- value
- 28
- group Id
- OG010
- value
- 24
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
- 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
- Safety population included all participants who receive at least one dose of study medication.
- reporting Status
- POSTED
- time Frame
- Baseline up to follow up visit (30 days after last dose of study treatment)
- title
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice