Duration of Treatment Administration Activities According to Healthcare Professionals' Responses on Perception of Time by Treatment Cycle, Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Treatment Room
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
minutes
Interval / dispersion
Full Range
Time frame
Day 1 of Cycles 1-6 (each cycle is 21 days)
What was measured
The Healthcare Professional Questionnaire (HCPQ)-Treatment Room Question 1 was completed at each treatment cycle of the Treatment Cross-Over Period by the healthcare professionals (HCPs) who administered treatment to the study's participants. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter, or peripheral vein cannulation) and how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the patient in the Treatment Room for in total?"
Analysis population: The number analyzed includes HCPs who completed question 1 of the survey per treatment cycle. For the questions related to IV access, the number analyzed only includes HCP responses for participants who required new IV access at a given treatment cycle.
Groups in this outcome
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
80
B: PH FDC SC Followed by P+H IV
80
Reported measurements
Cycle 1. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
4
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
4
6
Not reported
Cycle 1. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
1
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
5
5
Not reported
Cycle 1. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
50
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
1
40
Not reported
Cycle 1. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
79
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
150.0
Not reported
60
396
Not reported
B: PH FDC SC Followed by P+H IV
8.0
Not reported
2
17
Not reported
Cycle 1. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
79
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
300.0
Not reported
90
450
Not reported
B: PH FDC SC Followed by P+H IV
50.0
Not reported
8
240
Not reported
Cycle 2. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
4
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
3
5
Not reported
Cycle 2. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
1
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
3.0
Not reported
3
3
Not reported
Cycle 2. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
48
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
1
20
Not reported
Cycle 2. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
77
B: PH FDC SC Followed by P+H IV
80
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
90.0
Not reported
8
260
Not reported
B: PH FDC SC Followed by P+H IV
8.0
Not reported
5
20
Not reported
Cycle 2. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
77
B: PH FDC SC Followed by P+H IV
78
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
153.0
Not reported
30
342
Not reported
B: PH FDC SC Followed by P+H IV
40.0
Not reported
8
225
Not reported
Cycle 3. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
5
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
3
10
Not reported
Cycle 3. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
1
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
3.0
Not reported
3
3
Not reported
Cycle 3. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
48
B: PH FDC SC Followed by P+H IV
0
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
5.0
Not reported
1
30
Not reported
Cycle 3. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
80
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
70.0
Not reported
30
240
Not reported
B: PH FDC SC Followed by P+H IV
7.5
Not reported
4
16
Not reported
Cycle 3. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
79
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
150.0
Not reported
105
330
Not reported
B: PH FDC SC Followed by P+H IV
36.0
Not reported
5
327
Not reported
Cycle 4. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
7
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
5.0
Not reported
2
10
Not reported
Cycle 4. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
1
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
42.0
Not reported
42
42
Not reported
Cycle 4. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
36
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
5.0
Not reported
1
20
Not reported
Cycle 4. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
80
B: PH FDC SC Followed by P+H IV
77
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
8.0
Not reported
4
12
Not reported
B: PH FDC SC Followed by P+H IV
60.0
Not reported
30
210
Not reported
Cycle 4. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
78
B: PH FDC SC Followed by P+H IV
77
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
45.0
Not reported
1
185
Not reported
B: PH FDC SC Followed by P+H IV
150.0
Not reported
80
480
Not reported
Cycle 5. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
5
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
3.0
Not reported
2
10
Not reported
Cycle 5. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
1
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
10.0
Not reported
10
10
Not reported
Cycle 5. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
38
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
5.0
Not reported
1
20
Not reported
Cycle 5. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
77
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
8.0
Not reported
3
14
Not reported
B: PH FDC SC Followed by P+H IV
83.0
Not reported
30
200
Not reported
Cycle 5. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
77
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
33.0
Not reported
8
135
Not reported
B: PH FDC SC Followed by P+H IV
150.0
Not reported
95
343
Not reported
Cycle 6. Duration of Central Venous Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
6
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
10.0
Not reported
1
91
Not reported
Cycle 6. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
0
Cycle 6. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
0
B: PH FDC SC Followed by P+H IV
43
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
B: PH FDC SC Followed by P+H IV
5.0
Not reported
1
60
Not reported
Cycle 6. How Long Did it Take to Administer the Treatment?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
80
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
7.0
Not reported
3
11
Not reported
B: PH FDC SC Followed by P+H IV
60.0
Not reported
5
275
Not reported
Cycle 6. How Long Was the Patient in the Treatment Room in Total?
Analysis denominator · Participants
Group
Source count
A: P+H IV Followed by PH FDC SC
79
B: PH FDC SC Followed by P+H IV
80
Values in minutes · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
A: P+H IV Followed by PH FDC SC
35.0
Not reported
10
150
Not reported
B: PH FDC SC Followed by P+H IV
130.0
Not reported
45
330
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
4
upper Limit
6
value
5.0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
0
units
Participants
title
Cycle 1. Duration of Central Venous Catheter Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
5
upper Limit
5
value
5.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Cycle 1. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
40
value
5.0
denoms
counts
group Id
OG000
value
50
group Id
OG001
value
0
units
Participants
title
Cycle 1. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
60
upper Limit
396
value
150.0
group Id
OG001
lower Limit
2
upper Limit
17
value
8.0
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
79
units
Participants
title
Cycle 1. How Long Did it Take to Administer the Treatment?
categories
measurements
group Id
OG000
lower Limit
90
upper Limit
450
value
300.0
group Id
OG001
lower Limit
8
upper Limit
240
value
50.0
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
79
units
Participants
title
Cycle 1. How Long Was the Patient in the Treatment Room in Total?
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
5
value
5.0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
0
units
Participants
title
Cycle 2. Duration of Central Venous Catheter Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
3
value
3.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Cycle 2. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
20
value
5.0
denoms
counts
group Id
OG000
value
48
group Id
OG001
value
0
units
Participants
title
Cycle 2. Duration of Peripheral Vein Cannulation Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
8
upper Limit
260
value
90.0
group Id
OG001
lower Limit
5
upper Limit
20
value
8.0
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
80
units
Participants
title
Cycle 2. How Long Did it Take to Administer the Treatment?
categories
measurements
group Id
OG000
lower Limit
30
upper Limit
342
value
153.0
group Id
OG001
lower Limit
8
upper Limit
225
value
40.0
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
78
units
Participants
title
Cycle 2. How Long Was the Patient in the Treatment Room in Total?
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
10
value
5.0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
0
units
Participants
title
Cycle 3. Duration of Central Venous Catheter Set Up (IV Only)?
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
3
value
3.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Cycle 3. Duration of Peripherally Inserted Central Catheter Set Up (IV Only)?
denoms
counts
group Id
OG000
value
80
group Id
OG001
value
80
units
Participants
description
The Healthcare Professional Questionnaire (HCPQ)-Treatment Room Question 1 was completed at each treatment cycle of the Treatment Cross-Over Period by the healthcare professionals (HCPs) who administered treatment to the study's participants. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter, or peripheral vein cannulation) and how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the patient in the Treatment Room for in total?"
dispersion Type
Full Range
groups
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
OG000
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
OG001
title
B: PH FDC SC Followed by P+H IV
param Type
MEDIAN
population Description
The number analyzed includes HCPs who completed question 1 of the survey per treatment cycle. For the questions related to IV access, the number analyzed only includes HCP responses for participants who required new IV access at a given treatment cycle.
reporting Status
POSTED
time Frame
Day 1 of Cycles 1-6 (each cycle is 21 days)
title
Duration of Treatment Administration Activities According to Healthcare Professionals' Responses on Perception of Time by Treatment Cycle, Question 1 of the Healthcare Professional Questionnaire (HCPQ) - Treatment Room
Triangle