NCT03674112 · OUTCOME
Percentage of Healthcare Professionals (HCPs) by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Drug Preparation Room
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of HCPs
- Interval / dispersion
- Not reported
- Time frame
- Day 1 of Cycle 6 (each cycle is 21 days)
What was measured
Healthcare professionals (HCPs) who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Questions 3 and 4: "Looking back over the Perjeta-Herceptin treatment sessions, please indicate based on your opinion which administration method: Q3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Q4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The three available response options were: P+H IV, FDC SC, and No Difference.
Analysis population: The number analyzed includes healthcare professionals (HCPs) who completed any part of the survey at treatment Cycle 6.
Groups in this outcome
All Healthcare Professionals
This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, 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.
A: P+H IV Followed by PH FDC SC
In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration 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). 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.
B: PH FDC SC Followed by P+H IV
In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration 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 Healthcare Professionals | 160 |
| A: P+H IV Followed by PH FDC SC | 80 |
| B: PH FDC SC Followed by P+H IV | 80 |
Reported measurements
Q3. Answer: FDC SC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 87.5 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 92.5 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 82.5 | Not reported | Not reported | Not reported | Not reported |
Q3. Answer: P+H IV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 0.6 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 1.3 | Not reported | Not reported | Not reported | Not reported |
Q3. Answer: No Difference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 1.3 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 1.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 1.3 | Not reported | Not reported | Not reported | Not reported |
Q3. Answer: Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 10.6 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 6.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 15.0 | Not reported | Not reported | Not reported | Not reported |
Q4. Answer: FDC SC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 86.9 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 93.8 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 80.0 | Not reported | Not reported | Not reported | Not reported |
Q4. Answer: P+H IV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 0.0 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 0.0 | Not reported | Not reported | Not reported | Not reported |
Q4. Answer: No Difference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 2.5 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 5.0 | Not reported | Not reported | Not reported | Not reported |
Q4. Answer: Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Healthcare Professionals | 10.6 | Not reported | Not reported | Not reported | Not reported |
| A: P+H IV Followed by PH FDC SC | 6.3 | Not reported | Not reported | Not reported | Not reported |
| B: PH FDC SC Followed by P+H IV | 15.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87.5
- group Id
- OG001
- value
- 92.5
- group Id
- OG002
- value
- 82.5
- title
- Q3. Answer: FDC SC
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 1.3
- title
- Q3. Answer: P+H IV
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 1.3
- group Id
- OG002
- value
- 1.3
- title
- Q3. Answer: No Difference
- categories
- measurements
- group Id
- OG000
- value
- 10.6
- group Id
- OG001
- value
- 6.3
- group Id
- OG002
- value
- 15.0
- title
- Q3. Answer: Missing
- categories
- measurements
- group Id
- OG000
- value
- 86.9
- group Id
- OG001
- value
- 93.8
- group Id
- OG002
- value
- 80.0
- title
- Q4. Answer: FDC SC
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- title
- Q4. Answer: P+H IV
- categories
- measurements
- group Id
- OG000
- value
- 2.5
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 5.0
- title
- Q4. Answer: No Difference
- categories
- measurements
- group Id
- OG000
- value
- 10.6
- group Id
- OG001
- value
- 6.3
- group Id
- OG002
- value
- 15.0
- title
- Q4. Answer: Missing
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 80
- units
- Participants
- description
- Healthcare professionals (HCPs) who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Questions 3 and 4: "Looking back over the Perjeta-Herceptin treatment sessions, please indicate based on your opinion which administration method: Q3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Q4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The three available response options were: P+H IV, FDC SC, and No Difference.
- groups
- description
- This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, 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 Healthcare Professionals
- description
- In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration 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). 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
- A: P+H IV Followed by PH FDC SC
- description
- In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration 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
- OG002
- title
- B: PH FDC SC Followed by P+H IV
- param Type
- NUMBER
- population Description
- The number analyzed includes healthcare professionals (HCPs) who completed any part of the survey at treatment Cycle 6.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 6 (each cycle is 21 days)
- title
- Percentage of Healthcare Professionals (HCPs) by Their Responses on Perception of Time/Resource Use of Each Study Regimen, Questions 3 and 4 of the HCPQ - Drug Preparation Room
- type
- SECONDARY
- unit Of Measure
- Percentage of HCPs
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Preserved source evidence · Not medical advice
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