TriangleNCT02500043 · OUTCOME
Overall Response Rate (ORR)
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 the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
What was measured
Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
Analysis population: Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
Groups in this outcome
TAS-102+BSC
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
Placebo+BSC
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
| Group | Source count |
|---|---|
| TAS-102+BSC | 290 |
| Placebo+BSC | 145 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102+BSC | 4.5 | Not reported | 2.4 | 7.5 | Not reported |
| Placebo+BSC | 2.1 | Not reported | 0.4 | 5.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.4
- upper Limit
- 7.5
- value
- 4.5
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 5.9
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 145
- units
- Participants
- description
- Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
- id
- OG000
- title
- TAS-102+BSC
- description
- Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
- id
- OG001
- title
- Placebo+BSC
- param Type
- NUMBER
- population Description
- Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
- title
- Overall Response Rate (ORR)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice