TriangleNCT01327885 · OUTCOME
Overall Survival (OS)
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 date of treatment start until date of death from any cause, up to 5 years 5 months
What was measured
OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[ADI\] or leiomyosarcoma \[LMS\]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than \[\>\] 2 prior regimens).
Analysis population: Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
Groups in this outcome
Arm A: Eribulin Mesylate
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
Arm B: Dacarbazine
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
| Group | Source count |
|---|---|
| Arm A: Eribulin Mesylate | 228 |
| Arm B: Dacarbazine | 224 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Eribulin Mesylate | 13.5 | Not reported | 10.9 | 15.6 | Not reported |
| Arm B: Dacarbazine | 11.5 | Not reported | 9.6 | 13.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.618
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.954
- estimate Comment
- The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.
- group Description
- Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- =0.0169
- p Value Comment
- The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.768
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.618
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.954
- estimate Comment
- The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.
- group Description
- Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- =0.0169
- p Value Comment
- The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.768
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.9
- upper Limit
- 15.6
- value
- 13.5
- group Id
- OG001
- lower Limit
- 9.6
- upper Limit
- 13.0
- value
- 11.5
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 224
- units
- Participants
- description
- OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[ADI\] or leiomyosarcoma \[LMS\]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than \[\>\] 2 prior regimens).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
- id
- OG000
- title
- Arm A: Eribulin Mesylate
- description
- Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
- id
- OG001
- title
- Arm B: Dacarbazine
- param Type
- MEDIAN
- population Description
- Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From date of treatment start until date of death from any cause, up to 5 years 5 months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice