TriangleNCT02811861 · OUTCOME
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
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
- From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
What was measured
PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.
Analysis population: The FAS included all randomized participants regardless of the treatment actually received.
Groups in this outcome
Lenvatinib 18 mg Plus Everolimus 5 mg
Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Lenvatinib 20 mg Plus Pembrolizumab 200 mg
Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Sunitinib 50 mg
Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
| Group | Source count |
|---|---|
| Lenvatinib 18 mg Plus Everolimus 5 mg | 357 |
| Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 355 |
| Sunitinib 50 mg | 357 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 18 mg Plus Everolimus 5 mg | 14.7 | Not reported | 11.1 | 16.7 | Not reported |
| Lenvatinib 20 mg Plus Pembrolizumab 200 mg | 23.9 | Not reported | 20.8 | 27.7 | Not reported |
| Sunitinib 50 mg | 9.2 | Not reported | 6.0 | 11.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Stratified Hazard Ratio
- param Value
- 0.65
- statistical Comment
- Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.
- statistical Method
- Stratified Log-rank Test
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.49
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Stratified Hazard Ratio
- param Value
- 0.39
- statistical Comment
- Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.
- statistical Method
- Stratified Log-rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Stratified Hazard Ratio
- param Value
- 0.65
- statistical Comment
- Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.
- statistical Method
- Stratified Log-rank Test
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.49
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Stratified Hazard Ratio
- param Value
- 0.39
- statistical Comment
- Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.
- statistical Method
- Stratified Log-rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 16.7
- value
- 14.7
- group Id
- OG001
- lower Limit
- 20.8
- upper Limit
- 27.7
- value
- 23.9
- group Id
- OG002
- lower Limit
- 6.0
- upper Limit
- 11.0
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 357
- group Id
- OG001
- value
- 355
- group Id
- OG002
- value
- 357
- units
- Participants
- description
- PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
- id
- OG000
- title
- Lenvatinib 18 mg Plus Everolimus 5 mg
- description
- Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
- id
- OG001
- title
- Lenvatinib 20 mg Plus Pembrolizumab 200 mg
- description
- Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
- id
- OG002
- title
- Sunitinib 50 mg
- param Type
- MEDIAN
- population Description
- The FAS included all randomized participants regardless of the treatment actually received.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
- title
- Progression-free Survival (PFS) by Independent Imaging Review (IIR)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice