TriangleNCT02451943 · OUTCOME
Overall Survival (OS) Leiomyosarcoma (LMS)
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
- Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
What was measured
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Analysis population: All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40.
Groups in this outcome
Doxorubicin + Olaratumab
75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
Doxorubicin + Placebo
75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
| Group | Source count |
|---|---|
| Doxorubicin + Olaratumab | 119 |
| Doxorubicin + Placebo | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin + Olaratumab | 21.55 | Not reported | 18.63 | 27.63 | Not reported |
| Doxorubicin + Placebo | 21.88 | Not reported | 17.54 | 25.07 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.690
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.312
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7618
- param Type
- Hazard Ratio (HR)
- param Value
- 0.951
- statistical Comment
- Stratified
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.690
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.312
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7618
- param Type
- Hazard Ratio (HR)
- param Value
- 0.951
- statistical Comment
- Stratified
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.63
- upper Limit
- 27.63
- value
- 21.55
- group Id
- OG001
- lower Limit
- 17.54
- upper Limit
- 25.07
- value
- 21.88
- denoms
- counts
- group Id
- OG000
- value
- 119
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- id
- OG000
- title
- Doxorubicin + Olaratumab
- description
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- id
- OG001
- title
- Doxorubicin + Placebo
- param Type
- MEDIAN
- population Description
- All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40.
- reporting Status
- POSTED
- time Frame
- Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
- title
- Overall Survival (OS) Leiomyosarcoma (LMS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice