TriangleNCT03375320 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 60 months
What was measured
The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor \[NET\] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.
Groups in this outcome
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
| Group | Source count |
|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 134 |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 69 |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 64 |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 21.9 | Not reported | 18.8 | 30.4 | Not reported |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 19.7 | Not reported | 14.2 | 30.0 | Not reported |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 40.0 | Not reported | 31.3 | NA | Upper end of the confidence interval is not able to be estimated due to a low number of events |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31.1 | Not reported | 23.4 | NA | Upper end of the confidence interval is not able to be estimated due to a low number of events |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2438
- statistical Method
- One-sided stratified log-rank
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4426
- statistical Method
- One-sided stratified log-rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2438
- statistical Method
- One-sided stratified log-rank
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4426
- statistical Method
- One-sided stratified log-rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.8
- upper Limit
- 30.4
- value
- 21.9
- group Id
- OG001
- lower Limit
- 14.2
- upper Limit
- 30.0
- value
- 19.7
- comment
- Upper end of the confidence interval is not able to be estimated due to a low number of events
- group Id
- OG002
- lower Limit
- 31.3
- upper Limit
- NA
- value
- 40.0
- comment
- Upper end of the confidence interval is not able to be estimated due to a low number of events
- group Id
- OG003
- lower Limit
- 23.4
- upper Limit
- NA
- value
- 31.1
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 69
- group Id
- OG002
- value
- 64
- group Id
- OG003
- value
- 31
- units
- Participants
- description
- The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor \[NET\] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG000
- title
- Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG001
- title
- Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG002
- title
- Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG003
- title
- Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 60 months
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice