TriangleNCT01120184 · OUTCOME
Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent of work
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, Cycle 7 (Week 18)
What was measured
The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
Analysis population: Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.
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 | 67 |
| Trastuzumab Emtansine + Placebo | 64 |
| Trastuzumab Emtansine + Pertuzumab | 67 |
Reported measurements
% Work Time Missed at Baseline (n=66,63,67)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 15.3 | Not reported | 9.2 | 21.4 | Not reported |
| Trastuzumab Emtansine + Placebo | 9.5 | Not reported | 4.2 | 14.8 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 13.6 | Not reported | 7.7 | 19.6 | Not reported |
Change in % Work Time Missed (n=35,33,36)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 0.4 | Not reported | -7.3 | 8.2 | Not reported |
| Trastuzumab Emtansine + Placebo | -0.0 | Not reported | -4.5 | 4.5 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | -4.3 | Not reported | -13.0 | 4.6 | Not reported |
% Impairment While Working at Baseline(n=67,64,67)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 20.0 | Not reported | 14.1 | 25.9 | Not reported |
| Trastuzumab Emtansine + Placebo | 15.3 | Not reported | 9.5 | 21.1 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 19.9 | Not reported | 13.6 | 26.1 | Not reported |
Change in % Impairment While Working (n=34,32,35)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 8.8 | Not reported | 2.0 | 15.6 | Not reported |
| Trastuzumab Emtansine + Placebo | -0.3 | Not reported | -11.0 | 10.5 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | -2.7 | Not reported | -11.0 | 5.2 | Not reported |
% Overall Work Impairment at Baseline (n=65,62,66)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 28.5 | Not reported | 20.7 | 36.2 | Not reported |
| Trastuzumab Emtansine + Placebo | 21.2 | Not reported | 13.8 | 28.7 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 28.1 | Not reported | 20.3 | 35.9 | Not reported |
Change in % Overall Work Impairment (n=34,31,35)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 9.1 | Not reported | -0.4 | 18.6 | Not reported |
| Trastuzumab Emtansine + Placebo | -1.1 | Not reported | -13.0 | 11.0 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | -4.6 | Not reported | -14.0 | 5.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.2
- upper Limit
- 21.4
- value
- 15.3
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 14.8
- value
- 9.5
- group Id
- OG002
- lower Limit
- 7.7
- upper Limit
- 19.6
- value
- 13.6
- title
- % Work Time Missed at Baseline (n=66,63,67)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.3
- upper Limit
- 8.2
- value
- 0.4
- group Id
- OG001
- lower Limit
- -4.5
- upper Limit
- 4.5
- value
- -0.0
- group Id
- OG002
- lower Limit
- -13.0
- upper Limit
- 4.6
- value
- -4.3
- title
- Change in % Work Time Missed (n=35,33,36)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.1
- upper Limit
- 25.9
- value
- 20.0
- group Id
- OG001
- lower Limit
- 9.5
- upper Limit
- 21.1
- value
- 15.3
- group Id
- OG002
- lower Limit
- 13.6
- upper Limit
- 26.1
- value
- 19.9
- title
- % Impairment While Working at Baseline(n=67,64,67)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 15.6
- value
- 8.8
- group Id
- OG001
- lower Limit
- -11.0
- upper Limit
- 10.5
- value
- -0.3
- group Id
- OG002
- lower Limit
- -11.0
- upper Limit
- 5.2
- value
- -2.7
- title
- Change in % Impairment While Working (n=34,32,35)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.7
- upper Limit
- 36.2
- value
- 28.5
- group Id
- OG001
- lower Limit
- 13.8
- upper Limit
- 28.7
- value
- 21.2
- group Id
- OG002
- lower Limit
- 20.3
- upper Limit
- 35.9
- value
- 28.1
- title
- % Overall Work Impairment at Baseline (n=65,62,66)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.4
- upper Limit
- 18.6
- value
- 9.1
- group Id
- OG001
- lower Limit
- -13.0
- upper Limit
- 11.0
- value
- -1.1
- group Id
- OG002
- lower Limit
- -14.0
- upper Limit
- 5.0
- value
- -4.6
- title
- Change in % Overall Work Impairment (n=34,31,35)
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 67
- units
- Participants
- description
- The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
- 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
- Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 7 (Week 18)
- title
- Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
- type
- SECONDARY
- unit Of Measure
- percent of work
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice