TriangleNCT04322539 · OUTCOME
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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 randomization until the first documentation of best overall response (up to 22 months)
What was measured
DCR was defined as percentage of participants achieving a best overall response of confirmed CR, PR, or stable disease (SD) (for at least 7 weeks) per RECIST v1.1, as determined by the investigator. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline.
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 | 55.5 | Not reported | 50.9 | 60.1 | Not reported |
| Placebo + BSC Group | 16.1 | Not reported | 11.6 | 21.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 32.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 46.0
- estimate Comment
- The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.001
- p Value Comment
- p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.
- param Type
- Adjusted difference
- param Value
- 39.4
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 32.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 46.0
- estimate Comment
- The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.001
- p Value Comment
- p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.
- param Type
- Adjusted difference
- param Value
- 39.4
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.9
- upper Limit
- 60.1
- value
- 55.5
- group Id
- OG001
- lower Limit
- 11.6
- upper Limit
- 21.5
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 461
- group Id
- OG001
- value
- 230
- units
- Participants
- description
- DCR was defined as percentage of participants achieving a best overall response of confirmed CR, PR, or stable disease (SD) (for at least 7 weeks) per RECIST v1.1, as determined by the investigator. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline.
- 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
- NUMBER
- population Description
- ITT population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until the first documentation of best overall response (up to 22 months)
- title
- Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice