| Primary | Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device | 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. | Total Sample: All observations of an episode of care for the given treatment route. | Posted | | Mean | Standard Deviation | pounds | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
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| OG000 | Trastuzumab Single-Use Injection Device | 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. |
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| Primary | Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection | 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. | | Posted | | Mean | Standard Deviation | pounds | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion | 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. | | Posted | | Mean | Standard Deviation | pounds | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | 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. | Total Sample; number (n) of observations per task are shown. | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
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| OG000 | Trastuzumab Single-Use Injection Device | 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. |
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| Secondary | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | 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. | Total Sample; number (n) of observations per task are shown. | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | 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. | Total Sample; number (n) of observations per task are shown. | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 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. | Total Sample; number (n) of observations per task are shown. | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | Trastuzumab Single-Use Injection Device | 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. |
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| Secondary | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device | 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. | 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. | Posted | | Mean | Standard Deviation | consumables | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | Trastuzumab Single-Use Injection Device | 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. |
| |
| Secondary | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection | 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. | 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. | Posted | | Mean | Standard Deviation | consumables | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion | 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. | 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. | Posted | | Mean | Standard Deviation | consumables | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion | 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. | Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown. | Posted | | Mean | Standard Deviation | consumables | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | Trastuzumab Single-Use Injection Device | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab | 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. | | Posted | | Mean | Standard Deviation | minutes | | Data collection up to 1 year | Episodes of Care | Participants | | ID | Title | Description |
|---|
| OG000 | Trastuzumab Single-Use Injection Device | 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. | | OG001 | 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. | | OG002 | 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. |
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