Trial Outcomes & Findings for An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC) (NCT NCT02658461)
NCT ID: NCT02658461
Last Updated: 2016-04-29
Results Overview
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
Data collection up to 1 year
Results posted on
2016-04-29
Participant Flow
Eligible participants from the MO22982 (NCT01401166) trial were observed for this time and motion study of trastuzumab. The focus of the observation in this study was the HCP rather than the person being treated, so number of observations is reported everywhere instead of number of participants. Number of participants was not collected.
Each arm included 12 observations of an episode of care independent of the person being treated. By design of the study, some individuals may have been observed more than once and there may have been fewer than 12 actual participants in each arm. As only a single observation was required to participate, there was no "disposition" recorded.
Participant milestones
| Measure |
Trastuzumab Single-Use Injection Device
Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab Subcutaneous (SC) Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab Intravenous (IV) Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (\>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)
Baseline characteristics by cohort
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Participants
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
n=12 Participants
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
n=12 Participants
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=93 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=27 Participants
|
NA years
STANDARD_DEVIATION NA • n=483 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=93 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
NA Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=93 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
NA Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample: All observations of an episode of care for the given treatment route.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device
|
33.03 pounds
Standard Deviation 7.69
|
—
|
—
|
PRIMARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection
|
33.15 pounds
Standard Deviation 10.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion
Preparation
|
22.07 pounds
Standard Deviation 5.05
|
—
|
—
|
|
Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion
Administration
|
122.89 pounds
Standard Deviation 14.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample; number (n) of observations per task are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Pre-infusion set-up (n=9)
|
4.0 minutes
Standard Deviation 2.4
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Drug collection and check (n=10)
|
4.2 minutes
Standard Deviation 4.0
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Drug administration (n=12)
|
6.1 minutes
Standard Deviation 0.5
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Remove and discard device (n=12)
|
1.4 minutes
Standard Deviation 1.1
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Post-administration monitoring (n=5)
|
2.2 minutes
Standard Deviation 1.1
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Patient discharge (n=6)
|
2.2 minutes
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample; number (n) of observations per task are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Pre-infusion set-up (n=9)
|
2.9 minutes
Standard Deviation 1.8
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Drug preparation (n=12)
|
12.5 minutes
Standard Deviation 9.1
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Pre-administration monitoring (n=8)
|
3.5 minutes
Standard Deviation 3.1
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Drug administration (n=12)
|
5.3 minutes
Standard Deviation 2.2
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Remove and discard device (n=3)
|
0.3 minutes
Standard Deviation 0.6
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Post-administration monitoring (n=9)
|
1.9 minutes
Standard Deviation 0.8
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
Patient discharge (n=7)
|
1.4 minutes
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample; number (n) of observations per task are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Pre-infusion set-up (n=12)
|
8.6 minutes
Standard Deviation 4.3
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Drug collection and check (n=9)
|
4.6 minutes
Standard Deviation 3.0
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Drug administration (n=12)
|
32.5 minutes
Standard Deviation 2.1
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Monitoring during administration (n=4)
|
2.5 minutes
Standard Deviation 1.9
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Saline flush (n=12)
|
9.4 minutes
Standard Deviation 6.5
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Remove and discard supplies (n=11)
|
1.6 minutes
Standard Deviation 0.8
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Post-administration monitoring (n=2)
|
3.0 minutes
Standard Deviation 1.4
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
Patient discharge (n=9)
|
1.8 minutes
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample; number (n) of observations per task are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Prepare worksheet (n=9)
|
4.6 minutes
Standard Deviation 3.0
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Decontamination before aseptic unit (n=12)
|
7.2 minutes
Standard Deviation 5.6
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Ingredient check (n=12)
|
2.3 minutes
Standard Deviation 1.6
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Decontamination in aseptic unit (n=11)
|
20.7 minutes
Standard Deviation 15.0
|
—
|
—
|
|
Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Final product check and release (n=12)
|
2.6 minutes
Standard Deviation 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
|
16.0 minutes
Standard Deviation 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection
|
24.6 minutes
Standard Deviation 13.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion
|
58.1 minutes
Standard Deviation 5.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion
|
34.5 minutes
Standard Deviation 13.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=11 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Alcohol swabs (n=11)
|
1.2 consumables
Standard Deviation 0.4
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Aprons (n=7)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Dressing packs (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Gauze swabs (n=6)
|
1.2 consumables
Standard Deviation 0.4
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Pairs of gloves (n=10)
|
1.6 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device
Small plasters (n=7)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=8 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
25-gauge needles (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Alcohol swabs (n=6)
|
1.3 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Aprons (n=6)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Dressing packs (n=8)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Gauze swabs (n=4)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Pairs of gloves (n=7)
|
1.6 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Small plasters (n=7)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
10-milliliter (mL) syringes (n=4)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Mepore dressings (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Blue needles (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Clini-wipes (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Chloraprep swabs (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Wound care packs (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Mepore 9x10-centimeter (cm) dressings (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
5-mL syringes (n=6)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Orange needles (n=7)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Needles (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
6-mL syringes (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Green needles (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Leukomed T dressings (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Syringes (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Alco wipes (n=4)
|
1.3 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
Syringe caps (n=4)
|
1 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
20-mL Industrial Molding Supply (IMS) sprays (n=2)
|
1 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection
10-mL IMS sprays (n=1)
|
1 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
50-mL saline (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Alcohol swabs (n=12)
|
1.5 consumables
Standard Deviation 0.8
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Aprons (n=8)
|
2.8 consumables
Standard Deviation 0.7
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Connectors (n=8)
|
1.1 consumables
Standard Deviation 0.4
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Dressing packs (n=6)
|
1.5 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Gauze swabs (n=7)
|
2.3 consumables
Standard Deviation 1.9
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Giving sets (n=12)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Pairs of gloves (n=12)
|
3.0 consumables
Standard Deviation 1.0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
IV access equipment sets (n=11)
|
1.5 consumables
Standard Deviation 0.9
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Saline flushes (n=7)
|
1.7 consumables
Standard Deviation 0.8
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Small plasters (n=11)
|
1.1 consumables
Standard Deviation 0.3
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
10-mL syringes (n=4)
|
2.0 consumables
Standard Deviation 1.2
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Tegaderm IV dressings (n=10)
|
1.3 consumables
Standard Deviation 0.7
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
100-mL saline (n=9)
|
1.6 consumables
Standard Deviation 0.5
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Concept wound care packs (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Tourniquets (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
10-mL heparinised saline (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
21-gauge needles (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Mepore dressings (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
50-unit heparin (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
Blue needles (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
5-mL heparin (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion
250-mL saline (n=1)
|
2.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Alco/IMS wipes (n=10)
|
5.8 consumables
Standard Deviation 3.3
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
100-mL water injections (n=4)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
10-mL syringes (n=12)
|
3.0 consumables
Standard Deviation 1.7
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
10-mL water injections (n=8)
|
4.0 consumables
Standard Deviation 0.9
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
19-gauge needles (n=6)
|
2.7 consumables
Standard Deviation 2.6
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
21-gauge needles (n=8)
|
2.6 consumables
Standard Deviation 1.8
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
23-gauge needles (n=2)
|
3.5 consumables
Standard Deviation 0.7
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
250-mL saline bags (n=12)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
30-mL syringes (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Pairs of gloves (n=4)
|
2.3 consumables
Standard Deviation 1.3
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
20-mL IMS sprays (n=4)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
50-mL IMS sprays (n=3)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
0.2-cm Minisart filters (n=4)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Dressing packs (n=2)
|
1.0 consumables
Standard Deviation 0
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
1-mL syringes (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
10-mL sodium chloride (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Aprons (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
50-mL syringes (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Infusion hubs (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
|
Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion
Baxter caps (n=1)
|
1.0 consumables
Standard Deviation NA
Standard deviation not applicable for a single observation (n=1).
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab
|
56.7 minutes
Standard Deviation 30.3
|
30.3 minutes
Standard Deviation 14.9
|
94.5 minutes
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Data collection up to 1 yearPopulation: Total Sample
The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.
Outcome measures
| Measure |
Trastuzumab Single-Use Injection Device
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab SC Injection
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
Trastuzumab IV Infusion
n=12 Episodes of Care
Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed \>1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
|
|---|---|---|---|
|
Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab
|
30.0 minutes
Standard Deviation 14.4
|
19.8 minutes
Standard Deviation 12.4
|
75 minutes
Standard Deviation 20.9
|
Adverse Events
Trastuzumab Single-Use Injection Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trastuzumab SC Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trastuzumab IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER