TriangleNCT03674112 · OUTCOME
Percentage of Participants by Their Level of Satisfaction With the Respective Methods of Administration (IV and SC), Question 1 of the Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) and -Subcutaneous (TASQ-SC)
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
- Not reported
- Time frame
- Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days)
What was measured
The Therapy Administration Satisfaction Questionnaire (TASQ) is a 12-item, patient-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. The TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Cross-Over Period. Question 1 of the TASQ-IV/TASQ-SC is one of two items in the Satisfaction domain, with participants providing their answers to the following question: "How satisfied or dissatisfied were you with the IV infusion/SC injection?" The five available options for a participant's response were: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, and very dissatisfied.
Analysis population: Modified Intent-to-Treat (mITT) Population
Groups in this outcome
All Participants: TASQ-IV Completers
This analysis set includes all participants from Arms A and B who completed the TASQ-IV questionnaire, which was administered at the last IV treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
All Participants: TASQ-SC Completers
This analysis set includes all participants from Arms A and B who completed the TASQ-SC questionnaire, which was administered at the last SC treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
| Group | Source count |
|---|---|
| All Participants: TASQ-IV Completers | 160 |
| All Participants: TASQ-SC Completers | 160 |
Reported measurements
Very Satisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 25.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 57.5 | Not reported | Not reported | Not reported | Not reported |
Satisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 41.9 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 30.6 | Not reported | Not reported | Not reported | Not reported |
Neither Satisfied nor Dissatisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 25.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 4.4 | Not reported | Not reported | Not reported | Not reported |
Dissatisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 5.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 1.9 | Not reported | Not reported | Not reported | Not reported |
Very Dissatisfied
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 1.3 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 4.4 | Not reported | Not reported | Not reported | Not reported |
Did Not Answer Question
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 0.0 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 1.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25.6
- group Id
- OG001
- value
- 57.5
- title
- Very Satisfied
- categories
- measurements
- group Id
- OG000
- value
- 41.9
- group Id
- OG001
- value
- 30.6
- title
- Satisfied
- categories
- measurements
- group Id
- OG000
- value
- 25.6
- group Id
- OG001
- value
- 4.4
- title
- Neither Satisfied nor Dissatisfied
- categories
- measurements
- group Id
- OG000
- value
- 5.6
- group Id
- OG001
- value
- 1.9
- title
- Dissatisfied
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 4.4
- title
- Very Dissatisfied
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.3
- title
- Did Not Answer Question
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- The Therapy Administration Satisfaction Questionnaire (TASQ) is a 12-item, patient-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. The TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Cross-Over Period. Question 1 of the TASQ-IV/TASQ-SC is one of two items in the Satisfaction domain, with participants providing their answers to the following question: "How satisfied or dissatisfied were you with the IV infusion/SC injection?" The five available options for a participant's response were: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, and very dissatisfied.
- groups
- description
- This analysis set includes all participants from Arms A and B who completed the TASQ-IV questionnaire, which was administered at the last IV treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG000
- title
- All Participants: TASQ-IV Completers
- description
- This analysis set includes all participants from Arms A and B who completed the TASQ-SC questionnaire, which was administered at the last SC treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG001
- title
- All Participants: TASQ-SC Completers
- param Type
- NUMBER
- population Description
- Modified Intent-to-Treat (mITT) Population
- reporting Status
- POSTED
- time Frame
- Cycle 3 Day 1, Cycle 6 Day 1 (each cycle is 21 days)
- title
- Percentage of Participants by Their Level of Satisfaction With the Respective Methods of Administration (IV and SC), Question 1 of the Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) and -Subcutaneous (TASQ-SC)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice