TriangleNCT02500043 · OUTCOME
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline
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
- At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months)
What was measured
The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3.
Analysis population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
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 | 337 |
| Placebo+BSC | 170 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TAS-102+BSC | 4.3 | Not reported | 3.7 | 4.7 | Not reported |
| Placebo+BSC | 2.3 | Not reported | 2.0 | 2.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- 4.7
- value
- 4.3
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 2.8
- value
- 2.3
- denoms
- counts
- group Id
- OG000
- value
- 337
- group Id
- OG001
- value
- 170
- units
- Participants
- description
- The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3.
- 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
- MEDIAN
- population Description
- Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
- reporting Status
- POSTED
- time Frame
- At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months)
- title
- Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice