TriangleNCT03517449 · OUTCOME
Overall Survival (OS) in pMMR Participants
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
- Up to approximately 43 months
What was measured
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
Analysis population: Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.
Groups in this outcome
Lenvatinib 20 mg + Pembrolizumab 200 mg
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
| Group | Source count |
|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 346 |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 351 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 18.0 | Not reported | 14.9 | 20.5 | Not reported |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 12.2 | Not reported | 11.0 | 14.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Regression, Cox method
- p Value
- < 0.0001
- p Value Comment
- One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region, and prior history of pelvic radiation.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Regression, Cox method
- p Value
- < 0.0001
- p Value Comment
- One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region, and prior history of pelvic radiation.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.9
- upper Limit
- 20.5
- value
- 18.0
- group Id
- OG001
- lower Limit
- 11.0
- upper Limit
- 14.1
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 346
- group Id
- OG001
- value
- 351
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
- id
- OG000
- title
- Lenvatinib 20 mg + Pembrolizumab 200 mg
- description
- Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
- id
- OG001
- title
- Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel
- param Type
- MEDIAN
- population Description
- Analysis population consisted of ITT population which included all randomized participants. Data is reported for pMMR participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 43 months
- title
- Overall Survival (OS) in pMMR Participants
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice