TriangleNCT01120184 · OUTCOME
Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, Cycle 7 (Week 18)
What was measured
The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as \[mean score at the assessment visit minus mean score at Baseline\]. The higher the score, the higher the level of impairment or burden.
Analysis population: ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18).
Groups in this outcome
Trastuzumab + Taxane
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
Trastuzumab Emtansine + Placebo
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
Trastuzumab Emtansine + Pertuzumab
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
| Group | Source count |
|---|---|
| Trastuzumab + Taxane | 365 |
| Trastuzumab Emtansine + Placebo | 367 |
| Trastuzumab Emtansine + Pertuzumab | 363 |
Reported measurements
Baseline (n=344,355,344)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 85.0 | Not reported | 82.9 | 87.2 | Not reported |
| Trastuzumab Emtansine + Placebo | 85.5 | Not reported | 83.3 | 87.8 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 85.7 | Not reported | 83.5 | 87.8 | Not reported |
Change From Baseline at Cycle 7 (n=261,252,261)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | -1.6 | Not reported | -4.2 | 1.0 | Not reported |
| Trastuzumab Emtansine + Placebo | 2.3 | Not reported | 0.4 | 4.2 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | -0.2 | Not reported | -2.1 | 1.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.9
- upper Limit
- 87.2
- value
- 85.0
- group Id
- OG001
- lower Limit
- 83.3
- upper Limit
- 87.8
- value
- 85.5
- group Id
- OG002
- lower Limit
- 83.5
- upper Limit
- 87.8
- value
- 85.7
- title
- Baseline (n=344,355,344)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.2
- upper Limit
- 1.0
- value
- -1.6
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 4.2
- value
- 2.3
- group Id
- OG002
- lower Limit
- -2.1
- upper Limit
- 1.6
- value
- -0.2
- title
- Change From Baseline at Cycle 7 (n=261,252,261)
- denoms
- counts
- group Id
- OG000
- value
- 365
- group Id
- OG001
- value
- 367
- group Id
- OG002
- value
- 363
- units
- Participants
- description
- The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as \[mean score at the assessment visit minus mean score at Baseline\]. The higher the score, the higher the level of impairment or burden.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
- id
- OG000
- title
- Trastuzumab + Taxane
- description
- Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG001
- title
- Trastuzumab Emtansine + Placebo
- description
- Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG002
- title
- Trastuzumab Emtansine + Pertuzumab
- param Type
- MEAN
- population Description
- ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18).
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 7 (Week 18)
- title
- Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice