TriangleNCT03517449 · OUTCOME
Time to Treatment Failure Due to Toxicity in All-comer Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Months
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to approximately 77 months
What was measured
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.
Analysis population: Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
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 | 406 |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 388 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 456.5 | 520.6 | 520.6 | Not reported | Not reported |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 259.7 | 369.5 | 369.5 | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 520.6
- spread
- 520.6
- value
- 456.5
- group Id
- OG001
- lower Limit
- 369.5
- spread
- 369.5
- value
- 259.7
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 388
- units
- Participants
- description
- Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs.
- dispersion Type
- Standard Deviation
- 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
- GEOMETRIC_MEAN
- population Description
- Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 77 months
- title
- Time to Treatment Failure Due to Toxicity in All-comer Participants
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice