Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
Conditions
Keywords
patient preference, home administration, fixed-dose combination of pertuzumab and trastuzumab, subcutaneous administration
Brief summary
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Interventions
DRUGFixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W).
DRUGPertuzumab IV
Pertuzumab is given as a fixed dose of 840 mg intravenous (IV) loading dose and then 420 mg IV for subsequent maintenance doses once every 3 weeks.
DRUGTrastuzumab IV
Trastuzumab is given as an 8 milligram per kilogram (mg/kg) intravenous (IV) loading dose and then 6 mg/kg IV for subsequent maintenance doses once every 3 weeks.
DRUGTrastuzumab Emtansine
Trastuzumab emtansine will be given at a dose of 3.6 mg/kg by intravenous (IV) infusion, once every 3 weeks.
Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles).
PROCEDURESurgery
After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy.
RADIATIONRadiotherapy
After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Intact skin at planned site of subcutaneous (SC) injections * Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Negative human immunodeficiency virus (HIV) test at screening * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening * For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment * For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment Disease-specific Inclusion Criteria: * Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer * Primary tumor \>2 centimetres (cm) in diameter, or node-positive disease * HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018) * Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020) * Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes * Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines Inclusion Criteria for Treatment with Adjuvant PH FDC SC: * Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual * Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy
Exclusion criteria
* Stage IV (metastatic) breast cancer * History of concurrent or previously treated non-breast malignancies, except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years * Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Active, unresolved infections at screening requiring treatment * Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR) * Serious cardiac illness or medical conditions * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias * Inadequate bone marrow function * Impaired liver function * Renal function with creatinine clearance \<50 mL/min using the Cockroft-Gault formula and serum creatinine \>1.5x upper limit of normal (ULN) * Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment * Current severe, uncontrolled systemic disease that may interfere with planned treatment * Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study * Treatment with a live vaccine (e.g., FluMist) in the 30 days prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 90 days after the final dose of study treatment * Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis * Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma * Current chronic daily treatment with corticosteroids * Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol Cancer-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days) | The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV. Participants completed the PPQ, where Question (Q) 1 was: "All things considered, which setting for your treatment did you prefer?" Participants were required to select one of the following options: home, hospital or no preference. The reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting. Percentages were rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Day 1 of Cycles 1-8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1a: "Please indicate which treatment preparation the estimates relate to". HCPs were required to select one of the following options: PH FDC SC or P+H IV. The response to Q1a was used to further assess Q1b: How long did it take to prepare the treatment for use? Percentages were rounded off. |
| Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Day 1 of Cycles 1-8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1b: "How long did it take to prepare the treatment for use?" This was a follow up question to Q1a: "Please indicate which treatment preparation the estimates relate to" for which HCPs were required to select one of the following options: PH FDC SC or P+H IV. |
| Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Up to Day 1 of Cycle 8 (Cycle length = 21 days) | HCP=any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question 2 of the HCPQs: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Staff will have increased availability for other tasks in the pharmacy. 2b: Administrative procedures related to PH FDC SC require less time. 2c: Using PH FDC SC provides more flexibility for pharmacy staff in managing their workload. 2d: As PH FDC SC is fixed-dose, potential dosing errors are avoided. 2e: As PH FDC SC is fixed-dose, there is less drug wastage. 2f: Less storage space for PH FDC SC-related supplies is required in the pharmacy, as there is no need for reconstitution. 2g: Number of preparation steps \& staff time commitment are reduced. Percentages were rounded off. |
| Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Day 1 of Cycles 1-8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to. Q1b: Did the participant have existing IV access? Q1c: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided. Q1d: What type of existing IV access did the participant have? Q1e: When did the existing IV access place? Percentages were rounded off. PICC = peripherally inserted central catheter. |
| Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Day 1 of Cycles 1-8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1c: If new IV access was needed for this cycle of treatment, how long (in minutes) this took to set up? Q1f: How long (in minutes) did it take to administer the treatment (P+H IV or PH FDC SC)? Q1g: How long (in minutes) was the participant in the Treatment Area in total? Percentages have been rounded off. |
| Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period | Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days) | The percentage of participants who chose to receive PH FDC SC in the home setting or in the hospital setting during the treatment continuation period is reported. |
| Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Up to Cycle 8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation \&/or drug administration processes. HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Q2 (2a-2e) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Participants may be moved out of the Treatment Area (for infusion treatment) to receive PH FDC SC injections. 2b: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2c: Frees up infusion chairs for participants whose treatments can only be given IV. 2d: Waiting list for any P+H IV treatment at the Treatment Area is reduced. 2e: Staff's work burden is reduced, enhancing work performance. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off. |
| Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Up to Cycle 8 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation \&/or drug administration processes. HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Question 2 (2f to 2j) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2f: More interaction time between HCPs and participants. 2g: Staff have more time for further professional education/development. 2h: Staff has more time for administrative tasks. 2i: Participants on PH FDC SC spend less time in the Treatment Area. 2j: Participants prefer PH FDC SC to P+H IV. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off. |
| Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Up to Cycle 8 (Cycle length = 21 days) | HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Questions 3 to 11 of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care at your institution? Q5: Which required less time to administer (excluding observation period)? Q6: Which required less use of institutional resources (e.g., staff time, facility costs, equipment use)? Q7: Which required less time to administer all the treatment (including IV chemotherapy)? Q8: Which allowed for attending to more participants because of time savings from the mode of administration of pertuzumab and trastuzumab? Q9: During the NP you had to administer IV chemotherapy through participant's IV access. You prefer to accompany IV chemotherapy with? Q10: Which was preferred by participants? Q11: How frequently would you recommend PH FDC SC administration to your participants in the future? Percentages were rounded off. |
| Percentage of Participants Who Achieved pCR Post-surgery | Up to approximately 7.8 months | pCR was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0), according to the current American Joint Committee on Cancer (AJCC) staging system classification. Percentages were rounded off. |
| Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline, Day 1 of Cycles 6 and 8 (Cycle length = 21 days) | EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), global health status/quality of life (GHS/QoL) \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales. |
| Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline (Cycle 1) of Run-in Period; Day 1 of Cycles 1, 3, and 6 in the Cross-over Period (Cycle length = 21 days) | EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Day 1 of Cycles 3 and 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: Where was the treatment prepared? Q1c: Which healthcare professionals were involved in the treatment preparation processes? The 4 available response options for Q1a were: Participant's home, Hospital pharmacy, Day oncology unit, or Other. The 5 available response options for Q1c were: Physician, Nurse, Pharmacist, All of them or Other. Percentages were rounded off. |
| Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Day 1 of Cycles 3 and 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following parts of question Q1b: Q1b(1): How long did it take to prepare the treatment for use? Q1b(2): Time from the preparation place to reach the participant's home. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Day 1 of Cycle 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the questions 2, 3 and 4 of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant´s home, please indicate how strongly you agree or disagree with each of the following statements: 2a: Staff will have increased availability for other tasks in the hospital´s pharmacy. 2b: Administrative procedures related to PH FDC SC will require less time. 2c: Number of preparation steps and staff time commitment are reduced. The 5 response options were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree or Not applicable. Q3: Which took less time? Q4: Which required less use of institutional resources? The 4 available options were: Participant's home, In hospital, No difference, or Unsure. Percentages were rounded off. |
| Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Day 1 of Cycles 3 and 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: How long did it take to travel to the participant's home to administer PH FDC SC? Q1b: How long did it take for the participant to travel to the hospital to receive PH FDC SC? Q1c: How long did it take to administer PH FDC SC? Q1d: How long was the participant treatment time? Q1e: How much time did the participant spend in hospital? Q1f: How much time did you spend at the participant's home? From arrival to departure time. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Day 1 of Cycles 3 and 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1g. Does the participant still have implanted IV access? The 2 available responses were: Yes or No. Q1h: If question 1g was answered 'No', when was the IV access removed? The 3 available responses were: After surgery and before initiating adjuvant treatment; After initiating adjuvant treatment, or Not applicable. Q1i: If question 1g was answered 'Yes', what is the main reason to keep the IV access? The 5 available responses were: Local protocol; Risk of recurrence; Participant preference; Not applicable, or Other. Percentages were rounded off. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Day 1 of Cycle 6 (Cycle length = 21 days) | HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution? The 5 available responses were: \<12 months, ≥12 months, 18 months, \<24 months, ≥24 months. Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants? The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other. Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles? The 3 available responses were: Yes, No, and Unsure. Percentages were rounded off. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Day 1 of Cycle 6 (Cycle length = 21 days) | HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following question of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant's home, please indicate how strongly you agree/disagree with each of the following statements: 2a: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2b: Frees up infusion chairs or outpatient procedure rooms used to administer SC injections. 2c: Waiting list for infusion chairs or outpatient procedure rooms is reduced. 2d: Staff's work burden is reduced, enhancing work performance. 2e: More interaction time between HCPs and participants on IV treatment. 2f: Staff has more time for administrative tasks. 2g: Participants will spend less time in hospital. 2h: Participants prefer PH FDC SC at home. The 6 available responses were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree, \& Not applicable. |
| Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Day 1 of Cycle 6 (Cycle length = 21 days) | HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care? Q5: Which required less use of institutional resources? Q6: Which was preferred by participants? The 4 responses available were: Participant's home, In hospital, No difference, and Unsure. Q7: How frequently would you recommend PH FDC SC at home to your participants in the future? The 3 responses available were: Always, Sometimes, and Never. Percentages were rounded off. |
| Adjuvant Phase: HRQoL Assessed by EORTC QLQ C30 Scores in Participants Treated With Trastuzumab Emtansine IV | Day 1 of Cycles 1 and 6 (1 Cycle = 21 days) | EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales. |
| Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 7.4 months) | AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in left ventricular ejection fraction (LVEF) of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; congestive heart failure (CHF). AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort. |
| Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs | Up to Cycle 8 (1 Cycle = 21 days) | An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here. |
| Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 5.8 months) | AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort. |
| Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs | Up to Cycle 6 (Cycle length = 21 days) | An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here. |
| Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 3.5 years) | AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort. |
| Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With Premature Withdrawal From PH FDC SC and Trastuzumab Emtansine IV Due to AEs | From initiation of study treatment in the adjuvant phase until 28 days after the last treatment cycle (up to approximately 3.5 years) | An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinue study due to AEs will be reported. |
Countries
Argentina, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, India, Kenya, Mexico, Peru, Singapore, South Africa, South Korea, Spain, Turkey (Türkiye)
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 347 participants (1 participant was re-randomized to the same PH FDC SC arm) with early or locally advanced or inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer took part in the study at 45 investigative sites across 17 countries. The study is still ongoing. The health care professionals (HCPs) treating the participants were not enrolled in the study. The HCPs only completed the HCP questionnaire (HCPQ).
Pre-assignment details
Participants in Neoadjuvant Phase (NP) received either pertuzumab & trastuzumab intravenously (P+H IV) or as a fixed-dose combination, subcutaneously (PH FDC SC), along with chemotherapy. Participants who completed NP, underwent surgical resection & achieved pCR entered Adjuvant Phase to receive PH FDC SC in a run-in period, followed by a cross-over period & then a continuation period at home/hospital. Participants who had residual disease after surgery received trastuzumab emtansine IV.
Participants by arm
| Arm | Count |
|---|---|
| Arm A, Neoadjuvant Phase: P+H IV Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme). | 116 |
| Arm B, Neoadjuvant Phase: PH FDC SC Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme). | 231 |
| Total | 347 |
Baseline characteristics
| Characteristic | Total | Arm A, Neoadjuvant Phase: P+H IV | Arm B, Neoadjuvant Phase: PH FDC SC |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.5 | 50.9 years STANDARD_DEVIATION 11 | 52.9 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 145 Participants | 52 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants | 54 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 50 Participants | 15 Participants | 35 Participants |
| Race (NIH/OMB) Asian | 44 Participants | 12 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 10 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) White | 189 Participants | 66 Participants | 123 Participants |
| Sex: Female, Male Female | 346 Participants | 116 Participants | 230 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 4 / 228 | 0 / 194 | 0 / 190 | 0 / 191 | 0 / 84 | 0 / 114 | 1 / 117 |
| other Total, other adverse events | 113 / 115 | 222 / 228 | 84 / 194 | 77 / 190 | 64 / 191 | 26 / 84 | 31 / 114 | 107 / 117 |
| serious Total, serious adverse events | 19 / 115 | 43 / 228 | 3 / 194 | 1 / 190 | 1 / 191 | 1 / 84 | 0 / 114 | 9 / 117 |
Outcome results
Primary
Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)
The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV. Participants completed the PPQ, where Question (Q) 1 was: All things considered, which setting for your treatment did you prefer? Participants were required to select one of the following options: home, hospital or no preference. The reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting. Percentages were rounded off.
Time frame: Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)
Population: Adjuvant cross-over modified intent-to-treat (mITTcross) population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ, and completed radiotherapy before entering the cross-over period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | Home | 69.0 percentage of participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | Hospital | 23.0 percentage of participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | No Preference | 8.0 percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | Home | 59.0 percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | Hospital | 39.8 percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ) | No Preference | 1.2 percentage of participants |
Secondary
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: How long did it take to travel to the participant's home to administer PH FDC SC? Q1b: How long did it take for the participant to travel to the hospital to receive PH FDC SC? Q1c: How long did it take to administer PH FDC SC? Q1d: How long was the participant treatment time? Q1e: How much time did the participant spend in hospital? Q1f: How much time did you spend at the participant's home? From arrival to departure time.
Time frame: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ. Number analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ at the specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a | 65.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b | 60.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d | 30.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e | 120.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e | 120.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b | 60.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a | 82.5 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1f | 90.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a | 60.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b | 60.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d | 75.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e | 180.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1f | 90.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a | 85.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b | 60.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d | 30.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e | 120.0 minutes |
Secondary
Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following parts of question Q1b: Q1b(1): How long did it take to prepare the treatment for use? Q1b(2): Time from the preparation place to reach the participant's home.
Time frame: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ. Number analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1b(1) | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1b(2) | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1b(2) | 0.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1b(1) | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1b(2) | 3.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1b(2) | 1.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1b(1) | 4.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1b(1) | 5.0 minutes |
Secondary
Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity &/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Time frame: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 5.8 months)
Population: Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase. AEs for the cross-over period are pooled per treatment administration setting.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | AEs | 99 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | SAEs | 1 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | Cardiac AEs | 1 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | Grade ≥3 AEs | 6 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | Grade ≥3 AEs | 3 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | AEs | 89 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | Cardiac AEs | 2 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs | SAEs | 1 Participants |
Secondary
Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here.
Time frame: Up to Cycle 6 (Cycle length = 21 days)
Population: SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase. AEs for the cross-over period are pooled per treatment administration setting.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs | 2 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs | 2 Participants |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following question of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant's home, please indicate how strongly you agree/disagree with each of the following statements: 2a: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2b: Frees up infusion chairs or outpatient procedure rooms used to administer SC injections. 2c: Waiting list for infusion chairs or outpatient procedure rooms is reduced. 2d: Staff's work burden is reduced, enhancing work performance. 2e: More interaction time between HCPs and participants on IV treatment. 2f: Staff has more time for administrative tasks. 2g: Participants will spend less time in hospital. 2h: Participants prefer PH FDC SC at home. The 6 available responses were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree, & Not applicable.
Time frame: Day 1 of Cycle 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (Q2a-Q2h) of the HCPQ. Percentages were rounded off.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Strongly Disagree | 6.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Strongly Disagree | 6.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Disagree | 3.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Strongly Disagree | 6.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Neutral | 14.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Agree | 27.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Disagree | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Strongly Agree | 46.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Neutral | 7.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Strongly Disagree | 6.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Disagree | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Agree | 29.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Neutral | 19.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Agree | 26.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Strongly Agree | 55.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Strongly Agree | 43.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Strongly Agree | 47.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Neutral | 6.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Strongly Disagree | 6.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Neutral | 9.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Strongly Disagree | 7.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Neutral | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Agree | 30.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Agree | 24.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Strongly Agree | 67.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Strongly Disagree | 7.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Neutral | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Strongly Disagree | 6.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Strongly Agree | 55.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Disagree | 3.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Agree | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Neutral | 15.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Agree | 32.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Agree | 23.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Strongly Agree | 57.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Strongly Agree | 49.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Not Applicable | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Not Applicable | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Not Applicable | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Strongly Agree | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Not Applicable | 10.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Disagree | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Neutral | 25.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Agree | 22.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Disagree | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Neutral | 8.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Agree | 41.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Strongly Agree | 45.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2a: Not Applicable | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Strongly Disagree | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Disagree | 5.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Neutral | 6.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Agree | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Strongly Agree | 49.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2b: Not Applicable | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Strongly Disagree | 2.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Disagree | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Neutral | 5.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Agree | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Strongly Agree | 53.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2c: Not Applicable | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Disagree | 9.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Neutral | 14.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Agree | 25.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Not Applicable | 8.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Disagree | 2.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Neutral | 20.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2e: Agree | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Strongly Agree | 40.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2f: Not Applicable | 8.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Disagree | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Neutral | 6.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Agree | 32.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Strongly Agree | 56.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2g: Not Applicable | 4.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Strongly Disagree | 2.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Disagree | 18.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Neutral | 28.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Agree | 17.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2h: Strongly Agree | 29.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment | Q2d: Strongly Agree | 42.7 percentage of HCPs |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: Where was the treatment prepared? Q1c: Which healthcare professionals were involved in the treatment preparation processes? The 4 available response options for Q1a were: Participant's home, Hospital pharmacy, Day oncology unit, or Other. The 5 available response options for Q1c were: Physician, Nurse, Pharmacist, All of them or Other. Percentages were rounded off.
Time frame: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ. Number analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Physician | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Participant's Home | 95.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Day Oncology Unit | 17.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Nurse | 35.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6: Q1a: Day Oncology Unit | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Hospital Pharmacy | 72.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Other | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Pharmacist | 59.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Physician | 5.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Other | 9.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Nurse | 88.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: All of Them | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Pharmacist | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Participant's Home | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: All of them | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Other | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Other | 1.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Hospital Pharmacy | 4.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Other | 4.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Participant's Home | 90.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Hospital Pharmacy | 9.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Day Oncology Unit | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1a: Other | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Physician | 11.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Nurse | 75.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Pharmacist | 7.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: All of Them | 2.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 3 Day 1: Q1c: Other | 2.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Participant's Home | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Hospital Pharmacy | 71.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6: Q1a: Day Oncology Unit | 20.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1a: Other | 7.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Physician | 2.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Nurse | 29.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: Pharmacist | 58.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area | Cycle 6 Day 1: Q1c: All of them | 5.6 percentage of HCPs |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1g. Does the participant still have implanted IV access? The 2 available responses were: Yes or No. Q1h: If question 1g was answered 'No', when was the IV access removed? The 3 available responses were: After surgery and before initiating adjuvant treatment; After initiating adjuvant treatment, or Not applicable. Q1i: If question 1g was answered 'Yes', what is the main reason to keep the IV access? The 5 available responses were: Local protocol; Risk of recurrence; Participant preference; Not applicable, or Other. Percentages were rounded off.
Time frame: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ. Number analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: After Surgery and Before Adjuvant Treatment | 7.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g: Yes | 23.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Local Protocol | 45.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g: No | 76.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g: No | 64.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: After Surgery and Before Adjuvant Treatment | 10.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Risk of Recurrence | 10.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: After Initiating Adjuvant Treatment | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: After Initiating Adjuvant Treatment | 7.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: Not Applicable | 89.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Participant Preference | 25.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Local Protocol | 27.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Risk of Recurrence | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g: Yes | 35.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Participant Preference | 13.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Not Applicable | 15.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Not Applicable | 51.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: Not Applicable | 85.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Other | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Other | 5.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Other | 9.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g: Yes | 14.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g: No | 85.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: After Surgery and Before Adjuvant Treatment | 4.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: After Initiating Adjuvant Treatment | 10.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1h: Not Applicable | 85.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Local Protocol | 21.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Risk of Recurrence | 14.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Participant Preference | 14.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Not Applicable | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1i: Other | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g: Yes | 23.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g: No | 77.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: After Surgery and Before Adjuvant Treatment | 6.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: After Initiating Adjuvant Treatment | 6.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1h: Not Applicable | 87.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Risk of Recurrence | 4.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Participant Preference | 4.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Not Applicable | 38.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1i: Local Protocol | 42.9 percentage of HCPs |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution? The 5 available responses were: \<12 months, ≥12 months, 18 months, \<24 months, ≥24 months. Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants? The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other. Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles? The 3 available responses were: Yes, No, and Unsure. Percentages were rounded off.
Time frame: Day 1 of Cycle 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q1j to Q1l of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q1j to Q1l) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: <12 Months | 10.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: ≥12 Months | 28.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: 18 Months | 14.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: <24 Months | 3.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: ≥24 Months | 42.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: Before Surgery | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Surgery | 2.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After PCR Results | 15.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Completion of Full Adjuvant Therapy | 15.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Completion of IV Antineoplastic Within Adjuvant Therapy | 29.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: Other | 36.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: Yes | 11.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: No | 35.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: Unsure | 52.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: Other | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: <12 Months | 27.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After PCR Results | 20.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: ≥12 Months | 16.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: No | 37.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: 18 Months | 16.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Completion of Full Adjuvant Therapy | 28.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: <24 Months | 8.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: Yes | 37.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1j: ≥24 Months | 32.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Completion of IV Antineoplastic Within Adjuvant Therapy | 5.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: Before Surgery | 2.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1l: Unsure | 25.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment | Q1k: After Surgery | 10.3 percentage of HCPs |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the questions 2, 3 and 4 of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant´s home, please indicate how strongly you agree or disagree with each of the following statements: 2a: Staff will have increased availability for other tasks in the hospital´s pharmacy. 2b: Administrative procedures related to PH FDC SC will require less time. 2c: Number of preparation steps and staff time commitment are reduced. The 5 response options were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree or Not applicable. Q3: Which took less time? Q4: Which required less use of institutional resources? The 4 available options were: Participant's home, In hospital, No difference, or Unsure. Percentages were rounded off.
Time frame: Day 1 of Cycle 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any of the questions Q2, Q3, and Q4 of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2, and Q3, and Q4 of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Strongly Disagree | 4.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Neutral | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Agree | 43.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Strongly Agree | 38.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Not Applicable | 9.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Strongly Disagree | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Disagree | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Neutral | 13.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Agree | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Strongly Agree | 35.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Not Applicable | 9.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Strongly Disagree | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Disagree | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Neutral | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Agree | 39.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Strongly Agree | 38.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Not Applicable | 11.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: Participant's Home | 59.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: In hospital | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: No Difference | 11.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: Unsure | 26.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: Participant's Home | 73.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: In hospital | 5.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: No Difference | 8.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: Unsure | 12.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: In hospital | 36.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Strongly Disagree | 1.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Disagree | 18.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Disagree | 18.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: No Difference | 19.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Neutral | 16.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Neutral | 21.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Agree | 21.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: No Difference | 31.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Strongly Agree | 37.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Agree | 16.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2a: Not Applicable | 5.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: In hospital | 36.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Strongly Disagree | 2.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Strongly Agree | 37.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Disagree | 24.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: Unsure | 9.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Neutral | 13.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Not Applicable | 5.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Agree | 18.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: Unsure | 5.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Strongly Agree | 35.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q3: Participant's Home | 22.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2b: Not Applicable | 5.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q4: Participant's Home | 38.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area | Q2c: Strongly Disagree | 0 percentage of HCPs |
Secondary
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care? Q5: Which required less use of institutional resources? Q6: Which was preferred by participants? The 4 responses available were: Participant's home, In hospital, No difference, and Unsure. Q7: How frequently would you recommend PH FDC SC at home to your participants in the future? The 3 responses available were: Always, Sometimes, and Never. Percentages were rounded off.
Time frame: Day 1 of Cycle 6 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q7 of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q3 to Q7) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Never | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: Participant's Home | 84.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: In Hospital | 7.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: No Difference | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: Unsure | 2.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: Participant's Home | 80.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: In Hospital | 7.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: No Difference | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: Unsure | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: Participant's Home | 67.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: In Hospital | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: No Difference | 17.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: Unsure | 8.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: Participant's Home | 79.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: In Hospital | 11.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: No Difference | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: Unsure | 3.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Always | 80.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Sometimes | 17.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Always | 43.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: In Hospital | 27.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: Participant's Home | 45.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: No Difference | 6.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: In Hospital | 40.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: No Difference | 16.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: No Difference | 6.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Never | 12.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q3: Unsure | 6.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: Unsure | 16.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: Participant's Home | 28.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: Unsure | 6.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: In Hospital | 52.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: Participant's Home | 41.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: No Difference | 12.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q7: Sometimes | 43.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q4: Unsure | 6.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q6: In Hospital | 44.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment | Q5: Participant's Home | 40.5 percentage of HCPs |
Secondary
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales. A positive change from baseline=deterioration & negative change=improvement in symptom scales.
Time frame: Baseline (Cycle 1) of Run-in Period; Day 1 of Cycles 1, 3, and 6 in the Cross-over Period (Cycle length = 21 days)
Population: mITTcross population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ and completed radiotherapy before entering the cross-over period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - PF | 4.13 score on a scale | Standard Deviation 16.97 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Nausea & Vomiting | -0.57 score on a scale | Standard Deviation 11.43 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - EF | -0.95 score on a scale | Standard Deviation 21.86 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Nausea & Vomiting | -0.95 score on a scale | Standard Deviation 12.21 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - GHS/QoL | 2.08 score on a scale | Standard Deviation 14.53 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Pain | 22.51 score on a scale | Standard Deviation 20.84 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - CF | 84.54 score on a scale | Standard Deviation 21.14 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Pain | -5.30 score on a scale | Standard Deviation 21.82 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - RF | 78.35 score on a scale | Standard Deviation 21.4 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Pain | -6.37 score on a scale | Standard Deviation 20.18 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - FF | -3.37 score on a scale | Standard Deviation 21.05 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Pain | -6.06 score on a scale | Standard Deviation 23.59 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - PF | 2.50 score on a scale | Standard Deviation 13.19 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Dyspnoea | 7.56 score on a scale | Standard Deviation 17.68 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - CF | -2.08 score on a scale | Standard Deviation 21.11 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Dyspnoea | 1.89 score on a scale | Standard Deviation 20.44 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - RF | 4.92 score on a scale | Standard Deviation 21.61 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Dyspnoea | 0.00 score on a scale | Standard Deviation 20.84 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - CF | -2.65 score on a scale | Standard Deviation 22.3 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Dyspnoea | 0.38 score on a scale | Standard Deviation 17.86 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - GHS/QoL | -0.57 score on a scale | Standard Deviation 16.61 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Insomnia | 25.09 score on a scale | Standard Deviation 27.23 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - SF | 80.58 score on a scale | Standard Deviation 22.65 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Insomnia | -1.12 score on a scale | Standard Deviation 27.27 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - RF | 6.25 score on a scale | Standard Deviation 23.61 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Insomnia | 0.00 score on a scale | Standard Deviation 27.68 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - SF | 1.69 score on a scale | Standard Deviation 22.34 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Insomnia | 0.76 score on a scale | Standard Deviation 28.58 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1- GHS/QoL | 0.66 score on a scale | Standard Deviation 13.72 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Appetite loss | 10.65 score on a scale | Standard Deviation 18.35 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - SF | 1.70 score on a scale | Standard Deviation 20.69 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Appetite loss | 2.27 score on a scale | Standard Deviation 27.59 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - RF | 9.66 score on a scale | Standard Deviation 23.53 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Appetite loss | -0.38 score on a scale | Standard Deviation 25.01 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - SF | 0.95 score on a scale | Standard Deviation 21.64 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Appetite loss | -1.14 score on a scale | Standard Deviation 24.47 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - PF | 82.61 score on a scale | Standard Deviation 15.89 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Constipation | 13.75 score on a scale | Standard Deviation 22.95 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Fatigue | 26.92 score on a scale | Standard Deviation 21.92 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Constipation | -2.62 score on a scale | Standard Deviation 21.45 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - EF | 82.22 score on a scale | Standard Deviation 19.31 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Constipation | -4.92 score on a scale | Standard Deviation 23.99 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Fatigue | -3.62 score on a scale | Standard Deviation 17.55 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Constipation | -3.79 score on a scale | Standard Deviation 27.88 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - PF | 2.50 score on a scale | Standard Deviation 13.65 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Diarrhoea | 12.37 score on a scale | Standard Deviation 25.15 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Diarrhoea | 0.00 score on a scale | Standard Deviation 26.74 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Fatigue | -3.66 score on a scale | Standard Deviation 18.66 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Diarrhoea | -0.38 score on a scale | Standard Deviation 24.5 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - EF | -1.22 score on a scale | Standard Deviation 18.44 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Diarrhoea | 1.89 score on a scale | Standard Deviation 29.62 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Fatigue | -4.42 score on a scale | Standard Deviation 24.09 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Financial difficulties | 28.18 score on a scale | Standard Deviation 34.14 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - GHS/QoL | 76.98 score on a scale | Standard Deviation 17.09 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Financial Difficulties | -6.37 score on a scale | Standard Deviation 24.04 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Nausea & Vomiting | 4.64 score on a scale | Standard Deviation 10.96 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Financial Difficulties | -4.92 score on a scale | Standard Deviation 27 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - EF | 2.27 score on a scale | Standard Deviation 16.75 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Financial Difficulties | -2.65 score on a scale | Standard Deviation 27.32 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Nausea & Vomiting | -0.95 score on a scale | Standard Deviation 11.95 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Financial Difficulties | -6.35 score on a scale | Standard Deviation 30.82 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - PF | 80.35 score on a scale | Standard Deviation 16.2 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - PF | 1.83 score on a scale | Standard Deviation 14.44 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - GHS/QoL | 71.79 score on a scale | Standard Deviation 18.63 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1- GHS/QoL | 0.09 score on a scale | Standard Deviation 18.57 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - GHS/QoL | 5.15 score on a scale | Standard Deviation 20.59 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - GHS/QoL | 2.48 score on a scale | Standard Deviation 19.99 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - PF | 5.99 score on a scale | Standard Deviation 14.18 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - PF | 2.46 score on a scale | Standard Deviation 14.99 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - RF | 66.67 score on a scale | Standard Deviation 29.72 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - RF | 10.62 score on a scale | Standard Deviation 27.84 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - RF | 17.23 score on a scale | Standard Deviation 31.33 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - RF | 16.07 score on a scale | Standard Deviation 31.73 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - EF | 76.65 score on a scale | Standard Deviation 22.61 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - EF | 0.34 score on a scale | Standard Deviation 23.55 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - EF | 3.46 score on a scale | Standard Deviation 18.84 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - EF | 0.60 score on a scale | Standard Deviation 19.86 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - CF | 79.51 score on a scale | Standard Deviation 24.24 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - FF | 0.00 score on a scale | Standard Deviation 22.5 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - CF | 1.12 score on a scale | Standard Deviation 21.14 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - CF | 0.00 score on a scale | Standard Deviation 24.54 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - SF | 70.49 score on a scale | Standard Deviation 25.87 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - SF | 6.59 score on a scale | Standard Deviation 27.76 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - SF | 9.74 score on a scale | Standard Deviation 25.23 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - SF | 9.92 score on a scale | Standard Deviation 25.89 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Fatigue | 31.83 score on a scale | Standard Deviation 23.56 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Fatigue | -0.61 score on a scale | Standard Deviation 24.31 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Fatigue | -7.99 score on a scale | Standard Deviation 21.65 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Fatigue | -4.37 score on a scale | Standard Deviation 23.84 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Nausea & Vomiting | 5.38 score on a scale | Standard Deviation 11.47 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Nausea & Vomiting | 1.83 score on a scale | Standard Deviation 14.79 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Nausea & Vomiting | -1.31 score on a scale | Standard Deviation 10.43 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Nausea & Vomiting | 0.99 score on a scale | Standard Deviation 12.77 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Pain | 28.82 score on a scale | Standard Deviation 26.1 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Pain | -7.14 score on a scale | Standard Deviation 23.46 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Pain | -9.74 score on a scale | Standard Deviation 25.97 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Pain | -8.73 score on a scale | Standard Deviation 27.19 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Dyspnoea | 8.68 score on a scale | Standard Deviation 17.6 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Dyspnoea | 0.73 score on a scale | Standard Deviation 21.65 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Dyspnoea | 0.75 score on a scale | Standard Deviation 21.89 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Dyspnoea | 0.40 score on a scale | Standard Deviation 21.64 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Insomnia | 28.13 score on a scale | Standard Deviation 32.92 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Insomnia | 4.40 score on a scale | Standard Deviation 31.51 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Insomnia | -3.00 score on a scale | Standard Deviation 34.68 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Insomnia | 0.00 score on a scale | Standard Deviation 37.67 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Appetite loss | 11.81 score on a scale | Standard Deviation 21.07 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Appetite loss | 2.56 score on a scale | Standard Deviation 29.07 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Appetite loss | 0.00 score on a scale | Standard Deviation 25.62 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Appetite loss | 0.00 score on a scale | Standard Deviation 25.87 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Constipation | 13.89 score on a scale | Standard Deviation 22.51 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Constipation | 0.00 score on a scale | Standard Deviation 19.25 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Constipation | 0.00 score on a scale | Standard Deviation 25.62 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Constipation | 1.98 score on a scale | Standard Deviation 21.55 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Diarrhoea | 4.76 score on a scale | Standard Deviation 33.17 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Diarrhoea | 2.25 score on a scale | Standard Deviation 32.1 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 6 Day 1 - Diarrhoea | 4.76 score on a scale | Standard Deviation 32.37 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Financial difficulties | 32.29 score on a scale | Standard Deviation 34.35 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 1 Day 1 - Financial Difficulties | -4.40 score on a scale | Standard Deviation 28.2 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Change at Cycle 3 Day 1 - Financial Difficulties | -6.37 score on a scale | Standard Deviation 29.68 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores | Baseline - Diarrhoea | 12.15 score on a scale | Standard Deviation 22.75 |
Secondary
Adjuvant Phase: HRQoL Assessed by EORTC QLQ C30 Scores in Participants Treated With Trastuzumab Emtansine IV
EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales. A positive change from baseline=deterioration & negative change=improvement in symptom scales.
Time frame: Day 1 of Cycles 1 and 6 (1 Cycle = 21 days)
Secondary
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), global health status/quality of life (GHS/QoL) & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning & symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL & high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement & negative change=worsening in QoL & functioning scales. A positive change from baseline=deterioration & negative change=improvement in symptom scales.
Time frame: Baseline, Day 1 of Cycles 6 and 8 (Cycle length = 21 days)
Population: FASab included all randomized participants, regardless of whether they received treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - GHS/QoL | 79.86 score on a scale | Standard Deviation 18.4 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - GHS/QoL | -9.43 score on a scale | Standard Deviation 21.27 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - GHS/QoL | -10.42 score on a scale | Standard Deviation 19.73 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Physical functioning (PF) | 91.65 score on a scale | Standard Deviation 11.84 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - PF | -12.65 score on a scale | Standard Deviation 16.18 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - PF | -16.03 score on a scale | Standard Deviation 19.28 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Role Functioning (RF) | 91.88 score on a scale | Standard Deviation 15.82 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - RF | -15.85 score on a scale | Standard Deviation 28.78 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - RF | -19.87 score on a scale | Standard Deviation 27.62 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Emotional Functioning (EF) | 73.41 score on a scale | Standard Deviation 22.13 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - EF | -5.87 score on a scale | Standard Deviation 26.06 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - EF | 5.29 score on a scale | Standard Deviation 24.09 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Cognitive functioning (CF) | 88.41 score on a scale | Standard Deviation 19.01 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - CF | -12.02 score on a scale | Standard Deviation 22.39 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - CF | -9.62 score on a scale | Standard Deviation 25.21 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Social Functioning (SF) | 86.67 score on a scale | Standard Deviation 22.96 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - SF | -18.03 score on a scale | Standard Deviation 30.01 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - SF | -14.42 score on a scale | Standard Deviation 27.82 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Fatigue | 15.85 score on a scale | Standard Deviation 20.29 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Fatigue | 24.04 score on a scale | Standard Deviation 26.23 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Fatigue | 23.29 score on a scale | Standard Deviation 24.33 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Nausea & Vomiting | 4.06 score on a scale | Standard Deviation 11.6 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Nausea & Vomiting | 19.95 score on a scale | Standard Deviation 24.69 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Nausea & Vomiting | 3.21 score on a scale | Standard Deviation 20.88 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Pain | 12.17 score on a scale | Standard Deviation 18.25 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Pain | 14.21 score on a scale | Standard Deviation 27.53 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Pain | 11.86 score on a scale | Standard Deviation 29.21 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Dyspnoea | 4.35 score on a scale | Standard Deviation 14.32 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Dyspnoea | 8.74 score on a scale | Standard Deviation 23.49 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Dyspnoea | 13.46 score on a scale | Standard Deviation 28.97 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Insomnia | 25.22 score on a scale | Standard Deviation 30.14 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Insomnia | 4.37 score on a scale | Standard Deviation 32.48 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Insomnia | 8.97 score on a scale | Standard Deviation 40.75 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Appetite Loss | 8.41 score on a scale | Standard Deviation 20.16 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Appetite Loss | 21.31 score on a scale | Standard Deviation 32.22 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Appetite Loss | 16.03 score on a scale | Standard Deviation 33.97 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Constipation | 9.57 score on a scale | Standard Deviation 21.07 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Constipation | 7.65 score on a scale | Standard Deviation 29.44 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Constipation | 2.61 score on a scale | Standard Deviation 21.95 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Diarrhoea | 3.77 score on a scale | Standard Deviation 13.07 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Diarrhoea | 25.68 score on a scale | Standard Deviation 33.55 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Diarrhoea | 32.05 score on a scale | Standard Deviation 26.37 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Financial Difficulties | 26.09 score on a scale | Standard Deviation 34.14 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Financial Difficulties | 6.01 score on a scale | Standard Deviation 41.95 |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Financial Difficulties | 6.41 score on a scale | Standard Deviation 28.8 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Nausea & Vomiting | 14.80 score on a scale | Standard Deviation 22.82 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - GHS/QoL | 75.97 score on a scale | Standard Deviation 20.92 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Diarrhoea | 4.93 score on a scale | Standard Deviation 14.86 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - GHS/QoL | -7.40 score on a scale | Standard Deviation 24.64 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Nausea & Vomiting | 4.74 score on a scale | Standard Deviation 17.64 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - GHS/QoL | -11.75 score on a scale | Standard Deviation 26.78 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Appetite Loss | 23.99 score on a scale | Standard Deviation 33.89 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Physical functioning (PF) | 91.84 score on a scale | Standard Deviation 12.45 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Pain | 14.13 score on a scale | Standard Deviation 19.14 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - PF | -16.01 score on a scale | Standard Deviation 18.56 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Financial Difficulties | 23.17 score on a scale | Standard Deviation 32.67 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - PF | -13.00 score on a scale | Standard Deviation 16.25 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Pain | 7.79 score on a scale | Standard Deviation 25.83 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Role Functioning (RF) | 91.48 score on a scale | Standard Deviation 19.11 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Appetite Loss | 15.09 score on a scale | Standard Deviation 35.65 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - RF | -21.18 score on a scale | Standard Deviation 29.46 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Pain | 8.07 score on a scale | Standard Deviation 21.59 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - RF | -14.91 score on a scale | Standard Deviation 27.98 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Diarrhoea | 28.04 score on a scale | Standard Deviation 34.31 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Emotional Functioning (EF) | 71.45 score on a scale | Standard Deviation 22.54 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Dyspnoea | 6.28 score on a scale | Standard Deviation 16.45 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - EF | 1.01 score on a scale | Standard Deviation 25.2 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Constipation | 9.87 score on a scale | Standard Deviation 20.56 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - EF | 5.85 score on a scale | Standard Deviation 25.01 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Dyspnoea | 12.46 score on a scale | Standard Deviation 24.88 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Cognitive functioning (CF) | 88.19 score on a scale | Standard Deviation 17.62 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Financial Difficulties | -1.40 score on a scale | Standard Deviation 33.66 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - CF | -10.28 score on a scale | Standard Deviation 23.53 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Dyspnoea | 6.67 score on a scale | Standard Deviation 23.11 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - CF | -4.74 score on a scale | Standard Deviation 18.78 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Constipation | 5.61 score on a scale | Standard Deviation 25.69 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Social Functioning (SF) | 84.30 score on a scale | Standard Deviation 24.56 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Insomnia | 24.51 score on a scale | Standard Deviation 28.07 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - SF | -15.26 score on a scale | Standard Deviation 32.55 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Diarrhoea | 27.37 score on a scale | Standard Deviation 33.68 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - SF | -7.54 score on a scale | Standard Deviation 25.59 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Insomnia | 3.12 score on a scale | Standard Deviation 35.33 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Fatigue | 16.44 score on a scale | Standard Deviation 17.74 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Constipation | 3.86 score on a scale | Standard Deviation 24.73 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Fatigue | 27.21 score on a scale | Standard Deviation 25.91 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Insomnia | 9.12 score on a scale | Standard Deviation 33.84 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 8 Day 1 - Fatigue | 20.23 score on a scale | Standard Deviation 24.31 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Change at Cycle 6 Day 1 - Financial Difficulties | 7.79 score on a scale | Standard Deviation 35.93 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Nausea & Vomiting | 3.36 score on a scale | Standard Deviation 10.25 |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores | Baseline - Appetite Loss | 9.72 score on a scale | Standard Deviation 20.51 |
Secondary
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1c: If new IV access was needed for this cycle of treatment, how long (in minutes) this took to set up? Q1f: How long (in minutes) did it take to administer the treatment (P+H IV or PH FDC SC)? Q1g: How long (in minutes) was the participant in the Treatment Area in total? Percentages have been rounded off.
Time frame: Day 1 of Cycles 1-8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ. Number analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1g | 180.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1f | 180.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1f | 82.5 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1g | 300.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g | 280.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1g | 270.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1f | 145.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1g | 294.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g | 260.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1g | 190.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1g | 420.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c | 5.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1f | 90.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1g | 115.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1g | 150.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1f | 8.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1g | 180.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1g | 180.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c | 10.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1g | 180.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1g | 150.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c | 6.5 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1g | 120.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1g | 170.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c | 3.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1f | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1f | 8.0 minutes |
Secondary
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1b: How long did it take to prepare the treatment for use? This was a follow up question to Q1a: Please indicate which treatment preparation the estimates relate to for which HCPs were required to select one of the following options: PH FDC SC or P+H IV.
Time frame: Day 1 of Cycles 1-8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ. Number analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 3 Day 1 | 20.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 5 Day 1 | 20.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 6 Day 1 | 20.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 2 Day 1 | 20.5 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 7 Day 1 | 13.5 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 1 Day 1 | 20.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 8 Day 1 | 15.0 minutes |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 4 Day 1 | 20.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 8 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 5 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 1 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 3 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 4 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 6 Day 1 | 5.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 7 Day 1 | 4.0 minutes |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area | Cycle 2 Day 1 | 5.0 minutes |
Secondary
Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs
AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity &/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in left ventricular ejection fraction (LVEF) of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; congestive heart failure (CHF). AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Time frame: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 7.4 months)
Population: Neoadjuvant safety analysis set (SASab) included all randomized participants who received at least one study treatment during the neoadjuvant phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | AEs | 113 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | SAEs | 19 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | Grade ≥ 3 AEs | 46 Participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | Cardiac AEs | 1 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | Cardiac AEs | 3 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | AEs | 227 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | Grade ≥ 3 AEs | 103 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs | SAEs | 43 Participants |
Secondary
Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here.
Time frame: Up to Cycle 8 (1 Cycle = 21 days)
Population: SASab included all randomized participants who received at least one study treatment during the neoadjuvant phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs | 1 Participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs | 8 Participants |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to. HCPs were required to select one of the following options: PH FDC SC or P+H IV. The response to Q1a was used to further assess Q1b: How long did it take to prepare the treatment for use? Percentages were rounded off.
Time frame: Day 1 of Cycles 1-8 (Cycle length = 21 days)
Population: Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion. Overall number analyzed is the number of HCPs who answered Q1a of the HCPQ. Number analyzed is the number of HCPs who answered Q1a of the HCPQ at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 4 Day 1: PH FDC SC | 1.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 5 Day 1: PH FDC SC | 0.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 2 Day 1: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 1 Day 1: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 6 Day 1: PH FDC SC | 0.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 3 Day 1: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 6 Day 1: P+H IV | 99.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 5 Day 1: P+H IV | 99.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 7 Day 1: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 3 Day 1: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 7 Day 1: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 2 Day 1: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 8 Day 1: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 4 Day 1: P+H IV | 98.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 8 Day 1: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 1 Day 1: PH FDC SC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 8 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 3 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 1 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 1 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 2 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 2 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 3 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 4 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 4 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 5 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 5 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 6 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 6 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 7 Day 1: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 7 Day 1: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area | Cycle 8 Day 1: PH FDC SC | 100 percentage of HCPs |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation &/or drug administration processes. HCPs who have had experience with administration of P+H IV &/or PH FDC SC completed Question 2 (2f to 2j) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2f: More interaction time between HCPs and participants. 2g: Staff have more time for further professional education/development. 2h: Staff has more time for administrative tasks. 2i: Participants on PH FDC SC spend less time in the Treatment Area. 2j: Participants prefer PH FDC SC to P+H IV. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off.
Time frame: Up to Cycle 8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any sub part of Q2 (2f to 2j) of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (2f to 2j) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Agree | 30.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Neutral | 25.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Strongly Agree | 33.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Disagree | 8.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Not Applicable | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Agree | 31.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Strongly Disagree | 1.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Not Applicable | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Strongly Agree | 29.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Neutral | 4.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Agree | 33.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Agree | 26.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Not Applicable | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Strongly Agree | 61.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Strongly Disagree | 2.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Not Applicable | 6.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Strongly Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Strongly Disagree | 1.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Neutral | 20.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Disagree | 1.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Disagree | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Neutral | 20.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Disagree | 5.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Agree | 35.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Neutral | 23.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Strongly Agree | 35.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Strongly Agree | 31.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Not Applicable | 7.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Strongly Disagree | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Not Applicable | 12.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Strongly Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Disagree | 4.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Neutral | 34.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Agree | 22.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Strongly Agree | 28.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2f: Not Applicable | 7.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Strongly Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Disagree | 4.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Neutral | 36.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Agree | 22.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Strongly Agree | 25.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2g: Not Applicable | 7.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Strongly Disagree | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Disagree | 3.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Neutral | 31.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Agree | 25.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Strongly Agree | 28.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2h: Not Applicable | 8.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Strongly Disagree | 1.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Disagree | 1.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Neutral | 3.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Agree | 31.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Strongly Agree | 53.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2i: Not Applicable | 8.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Strongly Disagree | 0.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Disagree | 1.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Neutral | 21.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Agree | 31.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment | Q2j: Strongly Agree | 32.5 percentage of HCPs |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
HCPs who have had experience with administration of P+H IV &/or PH FDC SC completed Questions 3 to 11 of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care at your institution? Q5: Which required less time to administer (excluding observation period)? Q6: Which required less use of institutional resources (e.g., staff time, facility costs, equipment use)? Q7: Which required less time to administer all the treatment (including IV chemotherapy)? Q8: Which allowed for attending to more participants because of time savings from the mode of administration of pertuzumab and trastuzumab? Q9: During the NP you had to administer IV chemotherapy through participant's IV access. You prefer to accompany IV chemotherapy with? Q10: Which was preferred by participants? Q11: How frequently would you recommend PH FDC SC administration to your participants in the future? Percentages were rounded off.
Time frame: Up to Cycle 8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q11 of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q3 to Q11) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: PH FDC SC | 92.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: No Difference | 2.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: PH FDC SC | 69.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: Unsure | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: No Difference | 8.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: P+H IV | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: Unsure | 10.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: PH FDC SC | 73.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: Unsure | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: No Difference | 26.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: No Difference | 22.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: Unsure | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: P+H IV | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: P+H IV | 12.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: No Difference | 13.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: PH FDC SC | 73.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: PH FDC SC | 83.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: No Difference | 13.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: Unsure | 2.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: Unsure | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: No Difference | 17.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: P+H IV | 7.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: P+H IV | 5.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: PH FDC SC | 66.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: Unsure | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: No Difference | 10.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: P+H IV | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: Unsure | 15.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: P+H IV | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Always | 75.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: PH FDC SC | 68.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Sometimes | 24.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: PH FDC SC | 96.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Never | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: P+H IV | 8.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Never | 1.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: P+H IV | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: PH FDC SC | 83.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: No Difference | 8.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q3: Unsure | 6.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: P+H IV | 1.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: PH FDC SC | 82.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: No Difference | 13.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q4: Unsure | 3.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: P+H IV | 0.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: PH FDC SC | 97.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: No Difference | 1.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q5: Unsure | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: P+H IV | 0.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: PH FDC SC | 88.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: No Difference | 10.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q6: Unsure | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: PH FDC SC | 98.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: No Difference | 1.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q7: Unsure | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: P+H IV | 0.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: PH FDC SC | 82.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: No Difference | 16.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q8: Unsure | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: P+H IV | 8.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: PH FDC SC | 73.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: No Difference | 17.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q9: Unsure | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: P+H IV | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: PH FDC SC | 73.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: No Difference | 7.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q10: Unsure | 17.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Always | 79.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment | Q11: Sometimes | 19.0 percentage of HCPs |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to. Q1b: Did the participant have existing IV access? Q1c: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided. Q1d: What type of existing IV access did the participant have? Q1e: When did the existing IV access place? Percentages were rounded off. PICC = peripherally inserted central catheter.
Time frame: Day 1 of Cycles 1-8 (Cycle length = 21 days)
Population: Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion. Overall number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ. Number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: Other | 46.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: > 14 < 30 Days Prior Today | 20.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1a: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1a: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1b: Yes | 24.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1b: No | 75.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: Peripheral Vein Cannulation | 90.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: Central Venous Catheter | 9.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Central Venous Catheter | 40.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: PICC | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Port-a-Cath | 26.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: Within 7 Days Prior Today | 50.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: > 14 < 30 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: Other | 50.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1a: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1a: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1b: Yes | 23.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1b: No | 77.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: Peripheral Vein Cannulation | 88.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: Central Venous Catheter | 11.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Central Venous Catheter | 35.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: PICC | 28.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Port-a-Cath | 35.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: Within 7 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: > 14 < 30 Days Prior Today | 16.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: Other | 83.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b: Yes | 26.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b: No | 73.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: Peripheral Vein Cannulation | 88.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: PICC | 2.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: Central Venous Catheter | 9.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Central Venous Catheter | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: PICC | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Port-a-Cath | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: Within 7 Days Prior Today | 16.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: > 14 < 30 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: Other | 83.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1a: PH FDC SC | 1.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1a: P+H IV | 98.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1b: Yes | 32.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1b: No | 67.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: Peripheral Vein Cannulation | 89.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: Central Venous Catheter | 10.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Central Venous Catheter | 30.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: PICC | 35.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Port-a-Cath | 35.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: Within 7 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: > 14 < 30 Days Prior Today | 14.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: Other | 85.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1a: PH FDC SC | 0.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1a: P+H IV | 99.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1b: Yes | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1b: No | 66.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Port-a-cath | 1.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Peripheral Vein Cannulation | 93.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Central Venous Catheter | 5.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Central Venous Catheter | 19.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: PICC | 41.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Port-a-Cath | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Tunneled Central Venous Catheter | 5.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: Within 7 Days Prior Today | 21.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: > 7 < 14 Days Prior Today | 10.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: > 14 < 30 Days Prior Today | 15.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: Other | 52.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a: PH FDC SC | 0.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a: P+H IV | 99.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b: Yes | 34.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b: No | 65.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Port-a-cath | 2.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Peripheral Vein Cannulation | 94.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Central Venous Catheter | 2.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Central Venous Catheter | 16.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Port-a-Cath | 32.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Tunneled Central Venous Catheter | 8.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: Within 7 Days Prior Today | 25.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: > 14 < 30 Days Prior Today | 15.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: Other | 60.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1a: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1a: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1b: Yes | 28.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1b: No | 71.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: Peripheral Vein Cannulation | 97.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: Central Venous Catheter | 2.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Central Venous Catheter | 6.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: PICC | 50.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Port-a-Cath | 25.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Tunneled Central Venous Catheter | 18.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: Within 7 Days Prior Today | 38.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: > 14 < 30 Days Prior Today | 15.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: Other | 46.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1a: PH FDC SC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1a: P+H IV | 100 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1b: Yes | 33.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1b: No | 66.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: Peripheral Vein Cannulation | 97.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: Central Venous Catheter | 2.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Central Venous Catheter | 10.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: PICC | 47.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Port-a-Cath | 31.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Tunneled Central Venous Catheter | 10.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: Within 7 Days Prior Today | 20.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: > 7 < 14 Days Prior Today | 13.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: PICC | 43.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: Other | 53.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: > 14 < 30 Days Prior Today | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: Other | 57.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: > 14 < 30 Days Prior Today | 29.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: > 14 < 30 Days Prior Today | 5.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1b: Yes | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1b: No | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: Other | 54.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: Peripheral Vein Cannulation | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1b: Yes | 25.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Port-a-Cath | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1c: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1b: No | 75.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: PICC | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Port-a-cath | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Port-a-Cath | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: Other | 64.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Peripheral Vein Cannulation | 83.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: Within 7 Days Prior Today | 16.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: > 7 < 14 Days Prior Today | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: > 14 < 30 Days Prior Today | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 1 Day 1: Q1e: Other | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1c: Central Venous Catheter | 16.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1b: Yes | 66.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Central Venous Catheter | 16.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1b: Yes | 60.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1b: No | 40.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: Peripheral Vein Cannulation | 66.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1b: No | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Port-a-Cath | 83.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1c: Central Venous Catheter | 33.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: Within 7 Days Prior Today | 14.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Central Venous Catheter | 40.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: PICC | 20.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: Peripheral Vein Cannulation | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Port-a-Cath | 40.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: Within 7 Days Prior Today | 7.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: Within 7 Days Prior Today | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: > 7 < 14 Days Prior Today | 11.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: > 14 < 30 Days Prior Today | 62.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: > 14 < 30 Days Prior Today | 29.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 2 Day 1: Q1e: Other | 37.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 5 Day 1: Q1e: Other | 51.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1c: Central Venous Catheter | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b: Yes | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1b: No | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1b: Yes | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: Peripheral Vein Cannulation | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1c: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b: Yes | 40.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Central Venous Catheter | 57.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: PICC | 28.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1b: No | 60.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Port-a-Cath | 14.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: PICC | 20.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Port-a-cath | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: Within 7 Days Prior Today | 16.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1b: No | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: > 7 < 14 Days Prior Today | 8.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Peripheral Vein Cannulation | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: > 14 < 30 Days Prior Today | 25.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Port-a-Cath | 80.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 3 Day 1: Q1e: Other | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1a: PH FDC SC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1d: PICC | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1a: P+H IV | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1c: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1b: Yes | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1b: No | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: Peripheral Vein Cannulation | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: PICC | 14.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1c: Peripheral Vein Cannulation | 100 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1c: Central Venous Catheter | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Port-a-Cath | 85.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Central Venous Catheter | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: Within 7 Days Prior Today | 11.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: PICC | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Port-a-Cath | 50.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 8 Day 1: Q1e: > 7 < 14 Days Prior Today | 28.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1d: Tunneled Central Venous Catheter | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: Within 7 Days Prior Today | 6.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: Within 7 Days Prior Today | 7.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 7 Day 1: Q1e: > 7 < 14 Days Prior Today | 17.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: > 7 < 14 Days Prior Today | 0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 6 Day 1: Q1e: > 7 < 14 Days Prior Today | 9.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment | Cycle 4 Day 1: Q1e: > 14 < 30 Days Prior Today | 38.5 percentage of HCPs |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
HCP was defined as any personnel involved in the drug preparation &/or drug administration processes. HCPs who have had experience with administration of P+H IV &/or PH FDC SC completed Q2 (2a-2e) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Participants may be moved out of the Treatment Area (for infusion treatment) to receive PH FDC SC injections. 2b: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2c: Frees up infusion chairs for participants whose treatments can only be given IV. 2d: Waiting list for any P+H IV treatment at the Treatment Area is reduced. 2e: Staff's work burden is reduced, enhancing work performance. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off.
Time frame: Up to Cycle 8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered any sub part Q2 (2a to 2e) of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (2a to 2e) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Agree | 32.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Neutral | 12.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Strongly Agree | 39.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Strongly Agree | 32.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Not Applicable | 7.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Agree | 37.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Strongly Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Not Applicable | 8.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Disagree | 8.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Strongly Agree | 33.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Neutral | 15.3 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Disagree | 8.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Agree | 34.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Not Applicable | 7.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Strongly Agree | 35.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Strongly Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Not Applicable | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Strongly Disagree | 1.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Strongly Disagree | 0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Neutral | 14.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Disagree | 5.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Disagree | 9.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Neutral | 27.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Disagree | 9.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Agree | 26.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Neutral | 10.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Strongly Agree | 34.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Agree | 36.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Not Applicable | 6.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Strongly Disagree | 1.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Not Applicable | 7.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Strongly Disagree | 3.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Disagree | 13.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Strongly Agree | 33.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Neutral | 13.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Agree | 28.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2a: Not Applicable | 7.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Strongly Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Disagree | 6.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Neutral | 13.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Agree | 34.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Strongly Agree | 35.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2b: Not Applicable | 7.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Strongly Disagree | 3.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Disagree | 6.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Neutral | 10.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Agree | 35.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Strongly Agree | 37.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2c: Not Applicable | 7.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Strongly Disagree | 1.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Disagree | 6.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Neutral | 15.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Agree | 37.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Strongly Agree | 31.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2d: Not Applicable | 7.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Strongly Disagree | 3.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Disagree | 3.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Neutral | 25.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Agree | 27.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment | Q2e: Strongly Agree | 32.7 percentage of HCPs |
Secondary
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
HCP=any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question 2 of the HCPQs: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Staff will have increased availability for other tasks in the pharmacy. 2b: Administrative procedures related to PH FDC SC require less time. 2c: Using PH FDC SC provides more flexibility for pharmacy staff in managing their workload. 2d: As PH FDC SC is fixed-dose, potential dosing errors are avoided. 2e: As PH FDC SC is fixed-dose, there is less drug wastage. 2f: Less storage space for PH FDC SC-related supplies is required in the pharmacy, as there is no need for reconstitution. 2g: Number of preparation steps & staff time commitment are reduced. Percentages were rounded off.
Time frame: Up to Day 1 of Cycle 8 (Cycle length = 21 days)
Population: Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ. Number analyzed is the number of HCPs who responded to each sub-question of Q2 (Q2a-Q2g) of the HCPQ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Agree | 28.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Not Applicable | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Strongly Agree | 61.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Disagree | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Not Applicable | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Not Applicable | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Disagree | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Disagree | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Neutral | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Strongly Disagree | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Strongly Agree | 31.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Neutral | 11.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Agree | 58.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Strongly Agree | 47.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Not Available | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Agree | 28.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Disagree | 12.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Disagree | 5.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Strongly Agree | 50.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Neutral | 10.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Neutral | 13.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Strongly Agree | 24.7 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Not Applicable | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Agree | 53.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Neutral | 13.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Not available | 4.5 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Strongly Disagree | 1.1 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Disagree | 7.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Disagree | 2.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Neutral | 7.9 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Agree | 18.0 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Strongly Agree | 23.6 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Neutral | 2.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Agree | 56.2 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Strongly Agree | 52.8 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Not available | 3.4 percentage of HCPs |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Agree | 25.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Not available | 6.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Not Applicable | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Strongly Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Neutral | 11.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Agree | 38.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2a: Strongly Agree | 39.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Strongly Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Disagree | 15.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Neutral | 14.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Agree | 25.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Strongly Agree | 35.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2b: Not Applicable | 6.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Strongly Disagree | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Neutral | 14.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Agree | 41.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Strongly Agree | 34.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2c: Not Applicable | 6.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Strongly Disagree | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Disagree | 2.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Neutral | 7.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Agree | 36.0 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Strongly Agree | 46.3 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2d: Not Applicable | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Strongly Disagree | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Disagree | 3.7 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Neutral | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Strongly Agree | 35.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Agree | 47.6 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2e: Not Available | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Strongly Disagree | 1.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Disagree | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Neutral | 12.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Strongly Agree | 33.5 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Agree | 40.9 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2f: Not available | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Strongly Disagree | 1.8 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Disagree | 4.2 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Neutral | 6.1 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Strongly Agree | 36.4 percentage of HCPs |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area | Q2g: Agree | 44.8 percentage of HCPs |
Secondary
Percentage of Participants Who Achieved pCR Post-surgery
pCR was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0), according to the current American Joint Committee on Cancer (AJCC) staging system classification. Percentages were rounded off.
Time frame: Up to approximately 7.8 months
Population: FASab included all randomized participants, regardless of whether they received treatment. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Percentage of Participants Who Achieved pCR Post-surgery | 60.2 percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Percentage of Participants Who Achieved pCR Post-surgery | 60.9 percentage of participants |
Secondary
Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period
The percentage of participants who chose to receive PH FDC SC in the home setting or in the hospital setting during the treatment continuation period is reported.
Time frame: Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)
Population: The analysis includes all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC and entered the treatment continuation phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period | Choice of Home Setting | 68.8 Percentage of participants |
| Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home | Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period | Choice of Hospital Setting | 31.2 Percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period | Choice of Home Setting | 54.3 Percentage of participants |
| Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital | Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period | Choice of Hospital Setting | 45.7 Percentage of participants |
Secondary
Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity &/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Time frame: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 3.5 years)
Secondary
Treatment Continuation Period and Trastuzumab Emtansine IV Period: Number of Participants With Premature Withdrawal From PH FDC SC and Trastuzumab Emtansine IV Due to AEs
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinue study due to AEs will be reported.
Time frame: From initiation of study treatment in the adjuvant phase until 28 days after the last treatment cycle (up to approximately 3.5 years)