TriangleNCT01327885 · OUTCOME
Progression-Free Rate at 12 Weeks (PFR12wks)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization start until Week 12
What was measured
The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.
Analysis population: FAS (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 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 | 33.3 | Not reported | 27.2 | 39.9 | Not reported |
| Arm B: Dacarbazine | 28.6 | Not reported | 22.8 | 35.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.9
- estimate Comment
- The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.
- group Description
- The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.253
- p Value Comment
- The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.
- param Type
- Odds Ratio (OR)
- param Value
- 1.3
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.9
- estimate Comment
- The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.
- group Description
- The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.253
- p Value Comment
- The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.
- param Type
- Odds Ratio (OR)
- param Value
- 1.3
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.2
- upper Limit
- 39.9
- value
- 33.3
- group Id
- OG001
- lower Limit
- 22.8
- upper Limit
- 35.0
- value
- 28.6
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 224
- units
- Participants
- description
- The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.
- 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 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
- NUMBER
- population Description
- FAS (ITT analysis set) included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From date of randomization start until Week 12
- title
- Progression-Free Rate at 12 Weeks (PFR12wks)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice