TriangleNCT04322539 · OUTCOME
Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
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 randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months)
What was measured
PFS was defined as the time (months) from randomization until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1, or death from any cause, whichever comes first. More specifically, PFS was determined using all data until the last evaluable visit prior to or on the date of: (i) radiographic disease progression (PD) per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than the study drugs, whichever was earlier. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
Analysis population: ITT population included all randomized participants.
Groups in this outcome
Fruquintinib + BSC Group
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
Placebo + BSC Group
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
| Group | Source count |
|---|---|
| Fruquintinib + BSC Group | 461 |
| Placebo + BSC Group | 230 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib + BSC Group | 3.7 | Not reported | 3.5 | 3.8 | Not reported |
| Placebo + BSC Group | 1.8 | Not reported | 1.8 | 1.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.267
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.386
- estimate Comment
- The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < .001
- p Value Comment
- Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.321
- statistical Method
- stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.267
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.386
- estimate Comment
- The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < .001
- p Value Comment
- Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.321
- statistical Method
- stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 3.8
- value
- 3.7
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 1.9
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 461
- group Id
- OG001
- value
- 230
- units
- Participants
- description
- PFS was defined as the time (months) from randomization until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1, or death from any cause, whichever comes first. More specifically, PFS was determined using all data until the last evaluable visit prior to or on the date of: (i) radiographic disease progression (PD) per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than the study drugs, whichever was earlier. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
- id
- OG000
- title
- Fruquintinib + BSC Group
- description
- Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
- id
- OG001
- title
- Placebo + BSC Group
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months)
- title
- Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Independent clinical review pending · Not medical advice