TriangleNCT01956669 · OUTCOME
Overall Survival (OS) by Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From date of first dose of study treatment up to 61 months
What was measured
OS was defined as the time from the first dose of the study medication until death due to any cause. Only descriptive analysis performed.
Analysis population: mITT Set
Groups in this outcome
Cohort 1: Rhabdomyosarcoma (RMS)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 3: Ewing Sarcoma/pPNET (Ewing)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 4 (Osteosarcoma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
Cohort 7 (Hepatoblastoma)
Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
| Group | Source count |
|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 12 |
| Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) | 11 |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | 10 |
| Cohort 4 (Osteosarcoma) | 10 |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | 4 |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 4 |
| Cohort 7 (Hepatoblastoma) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Rhabdomyosarcoma (RMS) | 5.6 | Not reported | 2.2 | 14.2 | Not reported |
| Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) | 14.6 | Not reported | 1.5 | 20.1 | Not reported |
| Cohort 3: Ewing Sarcoma/pPNET (Ewing) | NA | Not reported | 4.3 | NA | NA: Not estimable due to insufficient number of participants with events |
| Cohort 4 (Osteosarcoma) | 5.5 | Not reported | 1.5 | 7.0 | Not reported |
| Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) | NA | Not reported | 2.6 | NA | NA: Not estimable due to insufficient number of participants with events |
| Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) | 5.4 | Not reported | 3.6 | 24.4 | Not reported |
| Cohort 7 (Hepatoblastoma) | 5.7 | Not reported | 0.6 | NA | NA: Not estimable due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.2
- upper Limit
- 14.2
- value
- 5.6
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 20.1
- value
- 14.6
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 4.3
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 1.5
- upper Limit
- 7.0
- value
- 5.5
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG004
- lower Limit
- 2.6
- upper Limit
- NA
- value
- NA
- group Id
- OG005
- lower Limit
- 3.6
- upper Limit
- 24.4
- value
- 5.4
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG006
- lower Limit
- 0.6
- upper Limit
- NA
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- OS was defined as the time from the first dose of the study medication until death due to any cause. Only descriptive analysis performed.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG000
- title
- Cohort 1: Rhabdomyosarcoma (RMS)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG001
- title
- Cohort 2: Non-rhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG002
- title
- Cohort 3: Ewing Sarcoma/pPNET (Ewing)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG003
- title
- Cohort 4 (Osteosarcoma)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG004
- title
- Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG005
- title
- Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)
- description
- Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
- id
- OG006
- title
- Cohort 7 (Hepatoblastoma)
- param Type
- MEDIAN
- population Description
- mITT Set
- reporting Status
- POSTED
- time Frame
- From date of first dose of study treatment up to 61 months
- title
- Overall Survival (OS) by Cohort
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice