TriangleNCT03517449 · OUTCOME
Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 77 months
What was measured
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Analysis population: Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
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 | 342 |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 325 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 140 | Not reported | Not reported | Not reported | Not reported |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 42 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 140
- group Id
- OG001
- value
- 42
- denoms
- counts
- group Id
- OG000
- value
- 342
- group Id
- OG001
- value
- 325
- units
- Participants
- description
- TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis population included all randomized participants who received at least 1 dose of study treatment. Data is reported for pMMR participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 77 months
- title
- Number of Participants Who Discontinued Study Treatment Due to a TEAE in pMMR Participants
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice