TriangleNCT02451943 · OUTCOME
Progression Free Survival (PFS)
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 Objective Progression or Death Due to Any Cause (Up to 35.8 Months)
What was measured
PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
Analysis population: All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34.
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 | 258 |
| Doxorubicin + Placebo | 251 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Doxorubicin + Olaratumab | 5.42 | Not reported | 4.11 | 6.70 | Not reported |
| Doxorubicin + Placebo | 6.77 | Not reported | 5.49 | 8.08 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.009
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.502
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0422
- param Type
- Hazard Ratio (HR)
- param Value
- 1.231
- statistical Comment
- Stratified
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.009
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.502
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0422
- param Type
- Hazard Ratio (HR)
- param Value
- 1.231
- statistical Comment
- Stratified
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.11
- upper Limit
- 6.70
- value
- 5.42
- group Id
- OG001
- lower Limit
- 5.49
- upper Limit
- 8.08
- value
- 6.77
- denoms
- counts
- group Id
- OG000
- value
- 258
- group Id
- OG001
- value
- 251
- units
- Participants
- description
- PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
- 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. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34.
- reporting Status
- POSTED
- time Frame
- Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice