Breast Cancer
Conditions
Brief summary
This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC. Participants who have completed the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of trastuzumab in this study. Participants will receive IV trastuzumab at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18).
Interventions
DRUGTrastuzumab
Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast * HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Hormonal therapy will be allowed as per institutional guidelines * Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment * Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment * No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant) * Use of concurrent curative radiotherapy will be permitted
Exclusion criteria
* History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible * Participants with severe dyspnea at rest or requiring supplementary oxygen therapy * Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension * Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) * Pregnant or lactating women * Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment * Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma * Inadequate bone marrow, hepatic or renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 45 months | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | 1 month after end of treatment (up to 10 months) | PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home? |
| Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days) | PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to Not at all, To a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home. |
| Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days) | MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom at its worst using 0-10 numerical rating scales with 0 = not present and 10 = as bad as you can imagine. Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome. |
| Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days) | PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to not at all, to a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Responses to question 11 with section A were categorized to Yes, but not long, yes, quite long, yes, much long and missing. Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home. |
| Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Prior (0 hours) to Cycle 12 (cycle length=21 days) | PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions? |
| Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Prior (0 hours) to Cycle 12 (cycle length=21 days) | HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study. |
| Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria | From start of treatment up to 45 months | DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible. |
| Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days) | MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome. |
Countries
Belgium, Israel
Participant flow
Pre-assignment details
Participants with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (eBC) who completed the first 6 cycles of trastuzumab intravenous (IV) as part of the (neo)adjuvant treatment received 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days). | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative/other | 1 | 0 |
| Overall Study | Adverse event/intercurrent illness | 4 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Did not cooperate | 1 | 0 |
| Overall Study | Disease progression/recurrence | 4 | 0 |
| Overall Study | Failure to return | 3 | 0 |
| Overall Study | Progression of disease | 2 | 0 |
| Overall Study | Recurrence of disease | 1 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 0 |
Baseline characteristics
| Characteristic | Trastuzumab |
|---|---|
| Age, Continuous | 54.38 Years STANDARD_DEVIATION 12.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 98 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 101 | 0 / 0 |
| other Total, other adverse events | 44 / 101 | 0 / 0 |
| serious Total, serious adverse events | 8 / 101 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.
Time frame: Up to 45 months
Population: Safety Population included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Emergent AEs | 90.1 percentage of participants |
| Trastuzumab | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Emergent SAEs | 7.9 percentage of participants |
Secondary
Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria
DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible.
Time frame: From start of treatment up to 45 months
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab | Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria | NA months |
Secondary
Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1)
HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study.
Time frame: Prior (0 hours) to Cycle 12 (cycle length=21 days)
Population: Health care professionals who participated in the study and completed the HCPEX-1 questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Quickest administration: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Specialty: Oncologist | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Specialty: Gynecologist | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Specialty: Oncologist/ Specialist Chemo Nurse | 19 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Specialty: Other | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Specialty: Missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personal administration of SC: always | 6 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personal administration of SC: sometimes | 15 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personal administration of SC: never | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personal administration of SC: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: <5 minutes | 7 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: 6-10 minutes | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: 11-15 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: 16-20 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: >20 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: not sure | 9 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC preparation: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: <3 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: <5 minutes | 16 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: 6-15 minutes | 3 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: 16-30 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: 31-60 minutes | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: 61-90 minutes | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: >90 minutes | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: not sure | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time required for SC administration: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for SC session: <2 hours | 14 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for SC session: 2-3 hours | 7 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for SC session: 3-4 hours | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for SC session: >4 hours | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for SC session: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliability of SC hand held syringe: not at all | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliability of SC hand held syringe: fairly | 10 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliability of SC hand held syringe: very | 11 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliability of SC hand held syringe: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Easy to administer SC hand held syringe:not at all | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Easy to administer SC hand held syringe: fairly | 13 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Easy to administer SC hand held syringe: very | 8 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Easy to administer SC hand held syringe: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | convenient method for IV treatment- cannula | 7 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | convenient method for IV treatment- VAD | 14 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | convenient method for IV treatment- not sure | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | convenient method for IV treatment- missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally administer IV: always | 4 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally administer IV: sometimes | 15 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally administer IV: never | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally administer IV: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally Cannulate: always | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally Cannulate: sometimes | 10 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally Cannulate: never | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Personally Cannulate: missing | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: <5 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: 6-10 minutes | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: 11-15 minutes | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: 16-20 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: >20 minutes | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: not sure | 10 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV preparation: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV session: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: <5 minutes | 8 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: 6-10 minutes | 4 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: 11-15 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: 16-20 minutes | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: >20 minutes | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: not sure | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for cannulation: missing | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: <3 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: <5 minutes | 3 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: 6-15 minutes | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: 16-30 minutes | 2 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: 31-60 minutes | 8 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: 61-90 minutes | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: >90 minutes | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: not sure | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for connection: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV session: <2 hours | 5 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV session: 2-3 hours | 11 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV session: 3-4 hours | 4 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Time for IV session: >4 hours | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Anxiety during IV treatment: not at all | 14 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Anxiety during IV treatment: fairly | 6 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Anxiety during IV treatment: very | 1 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Anxiety during IV treatment: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliablily of IV treatment: not at all | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliablily of IV treatment: fairly | 8 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliablily of IV treatment: very | 13 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Reliablily of IV treatment: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | IV administration easy: not at all | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | IV administration easy: fairly | 12 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | IV administration easy: very | 9 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | IV administration easy: missing | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Quickest administration: IV | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Quickest administration: SC (handheld syringe) | 21 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Quickest administration: no difference | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Require less resource: IV | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Require less resource: SC (handheld syringe) | 21 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Require less resource: no difference | 0 Health care professionals |
| Trastuzumab | Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1) | Require less resource: missing | 0 Health care professionals |
Secondary
Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital
PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions?
Time frame: Prior (0 hours) to Cycle 12 (cycle length=21 days)
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Place of study treatment: hospital chemo dept | 87 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling easy: not at all | 9 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling easy: fairly | 44 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Place of study treatment: other chemo clinic | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Place of study treatment: Doctor's office | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Place of study treatment: other | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Place of study treatment: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Same place as for your chemotherapy: yes | 87 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Same place as for your chemotherapy: no | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Same place as for your chemotherapy: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travel time: <1 hour | 70 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travel time: 1 to 2 hours | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travel time: >2 hours | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travel time: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Nursing and medical staff helpful: fairly | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Nursing and medical staff helpful: very | 72 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Nursing and medical staff helpful: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Pleasant place of treatment: not at all | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Pleasant place of treatment: fairly | 39 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Pleasant place of treatment: very | 44 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Pleasant place of treatment: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | IV administration method: cannula/needle | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | IV administration method:Venous Access Device(VAD) | 47 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | IV administration method: both | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | IV administration method: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | VAD: Hickman | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | VAD: peripherally inserted central catheters | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | VAD: port-a-cath | 47 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | VAD: other | 9 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | VAD: missing | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty inserting the cannula: very often | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty inserting the cannula: sometimes | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty inserting the cannula: never | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty inserting the cannula: missing | 60 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula: <5 minutes | 30 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula: 6-10 minutes | 7 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula: 11-15 minutes | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula:16-20 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula: >20 minutes | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for insertion of the cannula: missing | 62 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Cannulation painfull: not at all | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Cannulation painfull: fairly | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Cannulation painfull: very | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Cannulation painfull: missing | 60 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to the access port: <5 minutes | 39 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to access port: 6-10 minutes | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to access port: 11-15 minutes | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to access port: 16-20 minutes | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to access port: >20 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for connection to access port: missing | 53 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Connection painful: not at all | 36 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Connection painful: fairly | 14 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Connection painful: very | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Connection painful: missing | 52 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for IV session: <2 hours | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for IV session: 2-3 hours | 25 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for IV session: 3-4 hours | 26 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for IV session: >4 hours | 13 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for IV session: missing | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during IV treatment: not at all | 64 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during IV treatment: fairly | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during IV treatment: very | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during IV treatment: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General IV session: very unpleasant | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General IV session: fairly unpleasant | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General IV session: acceptable | 68 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General IV session: missing | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty in SC injection: very often | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty in SC injection: sometimes | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty in SC injection: never | 82 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Difficulty in SC injection: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: <5 minutes | 56 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: 6-10 minutes | 26 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: 11-15 minutes | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: 16-20 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: >20 minutes | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC injection: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | SC injection painful: not at all | 53 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | SC injection painful: fairly | 33 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | SC injection painful: very | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | SC injection painful: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC session: <2 hours | 46 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC session: 2-3 hours | 24 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC session: 3-4 hours | 9 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC session: >4 hours | 7 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Time for SC session: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during SC treatment: not at all | 63 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during SC treatment: fairly | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during SC treatment: very | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Anxiety during SC treatment: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General SC session: very unpleasant | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General SC session: fairly unpleasant | 7 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General SC session: acceptable | 79 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | General SC session: missing | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling easy: very | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling easy: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Company required for travelling: always | 32 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Company required for travelling: sometimes | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Company required for travelling: never | 36 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Company required for travelling: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling cost, a problem: not at all | 60 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling cost, a problem: fairly | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling cost, a problem: very | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling cost, a problem: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling overall, a problem: yes | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling overall, a problem: no | 69 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Travelling overall, a problem: missing | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital | Nursing and medical staff helpful: not at all | 0 participants |
Secondary
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital
PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to not at all, to a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Responses to question 11 with section A were categorized to Yes, but not long, yes, quite long, yes, much long and missing. Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home.
Time frame: Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)
Population: ITT population. Here, number of participants analysed included participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-To a small extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-To a moderate extent | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-To a large extent | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-To a very large extent | 49 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1a:Clinician Communication-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Not important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-A little important | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Important | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Very important | 40 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Of utmost importance | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 1b:Importance-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-To a moderate extent | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-To a large extent | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-To a very large extent | 56 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2a:Confidence in clinicians-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Important | 13 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Very important | 44 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Of utmost importance | 25 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 2b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-Not at all | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-To a moderate extent | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-To a large extent | 24 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-To very large extent | 51 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3a:Clinicians cared about you-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Important | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Very important | 47 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Of utmost importance | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 3b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-To a small extent) | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-To a moderate extent | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-To a large extent | 29 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-To a very large extent | 40 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-Not applicable | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4a:Clinicians interested-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Important | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Very important | 51 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Of utmost importance | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 4b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-Not at all | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-To small extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-To a moderate extent | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-To a large extent | 26 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinician-To a very large extent | 39 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-Not applicable | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5a:Time with clinicians-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Important | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Very important | 45 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Of utmost importance | 14 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 5b:Importance-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-To a moderate extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-To a large extent | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-To a very large extent | 60 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6a:Nurses communication-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Not important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-A little important | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Important | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Very important | 44 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Of utmost importance | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 6b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-To a moderate extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-To a large extent | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-To a very large extent | 61 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7a:Confidence in nurses-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Important | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Very important | 46 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Of utmost importance | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 7b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-Not at all | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-To a small extent | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-To a moderate extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-To a large extent | 25 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-To a very large extent | 52 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8a:Nurses cared about you-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-A little important | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Of utmost importance | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 8b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-To a small extent | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-To a moderate extent | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-To a large extent | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-To a very large extent | 56 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9a:Nurses interested-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-A little important | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Of utmost importance | 14 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 9b:Importance-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-To a small extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-To a moderate extent | 10 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-To a large extent | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-To a very large extent | 49 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-Not Applicable | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10a:Time with nurses-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-A little important | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Important | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Very important | 40 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Of utmost importance | 15 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 10b:Importance-Missing | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11a:Waited for hospital admission-No | 24 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11aWaited for hospital admission-Yes, but not long | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11a:Waited for hospital admission-Yes, quite long | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11a:Waited for hospital admission-Yes, much long | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11a:Waited for hospital admission-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Not important | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-A little important | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Important | 28 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Very important | 24 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Of utmost importance | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 11b:Importance-Missing | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment good order-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment good order-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment good order-To moderate extent | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment good order-To a large extent | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12aClinic equipment good order-To very large exten | 46 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment good order-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12a:Clinic equipment in good order-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Of utmost importance | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 12b:Importance-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-To moderate extent | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-To a large extent | 32 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13aClinic otherwise good order- Very large extent | 45 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13a:Clinic otherwise good order-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Important | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Very important | 39 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Of utmost importance | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 13b:Importance-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-To a moderate extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-To a large extent | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-To a very large extent | 65 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-Not Applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14a:Satisfactory treatment-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-A little important | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Important | 12 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Very important | 43 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Of utmost importance | 25 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital | 14b:Importance-Missing | 3 participants |
Secondary
Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home
PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to Not at all, To a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home.
Time frame: Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)
Population: ITT population. Here, number of participants analysed included participants who were evaluable for the outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-To a small extent | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-To a moderate extent | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-To a large extent | 28 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-To a very large extent | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-Not Applicable | 7 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1a:Clinicians communication-Missing | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Not important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Important | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Very important | 37 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Of utmost importance | 16 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-To moderate extent | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 1b:Importance-Missing | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-To a large extent | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in clinician-To very large extent | 51 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-Not applicable | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2a:Confidence in the clinicians-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Important | 14 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Very important | 38 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Of utmost importance | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 2b:Importance-Missing | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-Not at all | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-To a moderate extent | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-To a large extent | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinician cared about you-To very large extent | 42 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-Not Applicable | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3a:Clinicians cared about you-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Important | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Very important | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Of utmost importance | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 3b:Importance-Missing | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-To a moderate extent | 9 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-To a large extent | 27 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-To a very large extent | 36 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-Not applicable | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4a:Clinicians interested-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Important | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Very important | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Of utmost importance | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 4b:Importance-Missing | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-Not at all | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-To moderate extent | 11 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-To a large extent | 31 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-To very large extent | 30 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-Not Applicable | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5a:Clinicians interaction-Missing | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Very important | 35 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Of utmost importance | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 5b:Importance-Missing | 8 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-To a moderate extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-To a large extent | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-To a very large extent | 62 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-Not applicable | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6a:Nurses communication-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Very important | 39 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Of utmost importance | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 6b:Importance-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-To a moderate extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-To a large extent | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-To a very large extent | 58 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7a:Confidence in the nurses-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Important | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Of utmost importance | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 7b:Importance-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-To a moderate extent | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-To a large extent | 23 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-To a very large extent | 57 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8a:Nurses cared about you-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Important | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Very important | 38 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Of utmost importance | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 8b:Importance-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-To a moderate extent | 4 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-To a large extent | 29 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-To a very large extent | 49 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9a:Nurses interested-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Very important | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Of utmost importance | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-To a small extent | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-To a moderate extent | 6 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-To a large extent | 26 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-To a very large extent | 49 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Nurses interaction-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10a:Importance-A little important | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10b:Importance-Important | 27 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10b:Importance-Very important | 34 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10b:Importance-Of utmost importance | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 10b:Importance-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-To moderate extent | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-To a large extent | 27 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurse equipment good order-To verylarge extent | 51 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-Not applicable | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11a:Nurses equipment good order-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Not important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-A little important | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Important | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Of utmost importance | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 11b:Importance-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-To a moderate extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-To a large extent | 14 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-To a very large extent | 67 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Satisfaction-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12a:Importance-A little important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12b:Importance-Important | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12b:Importance-Very important | 42 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12b:Importance-Of utmost importance | 22 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 12b:Importance-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-Not at all | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-To a small extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-To moderate extent | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-To a large extent | 18 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-To very large extent | 63 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13a:Care benefit at home-Missing | 2 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Not important | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-A little important | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Important | 19 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Very important | 41 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Of utmost importance | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Not applicable | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 13b:Importance-Missing | 1 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home | 9b:Importance-Important | 27 participants |
Secondary
Number of Participants With Modalities Assessed Using PEX - Part 2: At Home
PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home?
Time frame: 1 month after end of treatment (up to 10 months)
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Difficulty in SC administration: very often | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Difficulty in SC administration: sometimes | 5 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Difficulty in SC administration: never | 77 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Difficulty in SC administration: missing | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: <5 minutes | 65 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: 6-10 minutes | 17 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: 11-15 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: 16-20 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: >20 minutes | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration time: missing | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration Painful: not at all | 61 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration Painful: fairly | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration Painful: very | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | SC administration Painful: missing | 21 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Time for SC session: <2 hours | 82 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Time for SC session: 2-3 hours | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Time for SC session: 3-4 hours | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Time for SC session: >4 hours | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Time for SC session: missing | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Anxiety during SC treatment: not at all | 71 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Anxiety during SC treatment: fairly | 11 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Anxiety during SC treatment: very | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | Anxiety during SC treatment: missing | 20 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | General SC session: very unpleasant | 3 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | General SC session: fairly unpleasant | 0 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | General SC session: acceptable | 79 participants |
| Trastuzumab | Number of Participants With Modalities Assessed Using PEX - Part 2: At Home | General SC session: missing | 20 participants |
Secondary
Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire
MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome.
Time frame: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)
Population: ITT population. Here, number of participants analysed included participants who were evaluable for the outcome measure and n included participants who were evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | General activity- IV (Hospital) - Cycle 7 | 2.77 units on a scale | Standard Deviation 2.73 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Mood- IV (Hospital) - Cycle 7 | 2.11 units on a scale | Standard Deviation 2.13 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Work- IV (Hospital) - Cycle 7 | 3.22 units on a scale | Standard Deviation 2.86 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Relations- IV (Hospital) - Cycle 7 | 1.54 units on a scale | Standard Deviation 2.13 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Walking- IV (Hospital) - Cycle 7 | 3.34 units on a scale | Standard Deviation 3.06 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Enjoyment of life- IV (Hospital) - Cycle 7 | 2.51 units on a scale | Standard Deviation 2.55 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | General activity- SC (Hospital) - Cycle 10 | 2.24 units on a scale | Standard Deviation 2.35 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Mood- SC (Hospital) - Cycle 10 | 1.92 units on a scale | Standard Deviation 2.28 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Work- SC (Hospital) - Cycle 10 | 2.63 units on a scale | Standard Deviation 2.71 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Relations- SC (Hospital) - Cycle 10 | 1.48 units on a scale | Standard Deviation 2.3 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Walking- SC (Hospital) - Cycle 10 | 2.38 units on a scale | Standard Deviation 2.69 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Enjoyment of life- SC (Hospital) - Cycle 10 | 2.21 units on a scale | Standard Deviation 2.67 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | General activity- SC (Home) - Cycle 13 | 2.27 units on a scale | Standard Deviation 2.48 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Mood- SC (Home) - Cycle 13 | 1.81 units on a scale | Standard Deviation 2.28 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Work- SC (Home) - Cycle 13 | 2.35 units on a scale | Standard Deviation 2.26 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Relations- SC (Home) - Cycle 13 | 1.13 units on a scale | Standard Deviation 1.93 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Walking- SC (Home) - Cycle 13 | 2.13 units on a scale | Standard Deviation 2.79 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Enjoyment of life- SC (Home) - Cycle 13 | 2.06 units on a scale | Standard Deviation 2.66 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | General activity- SC (Home) - Cycle 16 | 1.84 units on a scale | Standard Deviation 2.12 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Mood- SC (Home) - Cycle 16 | 1.76 units on a scale | Standard Deviation 2.13 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Work- SC (Home) - Cycle 16 | 2.00 units on a scale | Standard Deviation 2.21 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Relations- SC (Home) - Cycle 16 | 1.02 units on a scale | Standard Deviation 1.85 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Walking- SC (Home) - Cycle 16 | 1.67 units on a scale | Standard Deviation 2.41 |
| Trastuzumab | Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire | Enjoyment of life- SC (Home) - Cycle 16 | 1.90 units on a scale | Standard Deviation 2.37 |
Secondary
Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire
MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom at its worst using 0-10 numerical rating scales with 0 = not present and 10 = as bad as you can imagine. Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome.
Time frame: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)
Population: ITT population. Here, number of participants analysed included participants who were evaluable for the outcome measure and n included participants who were evaluable for the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Numbness- IV (Hospital) - Cycle 7 | 3.01 units on a scale | Standard Deviation 3.2 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Pain- SC (Hospital) - Cycle 10 | 1.81 units on a scale | Standard Deviation 2.14 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Fatigue- SC (Hospital) - Cycle 10 | 3.35 units on a scale | Standard Deviation 2.45 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Nausea- SC (Hospital) - Cycle 10 | 0.61 units on a scale | Standard Deviation 1.41 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Disturbed Sleep- SC (Hospital) - Cycle 10 | 2.70 units on a scale | Standard Deviation 2.86 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Distressed- SC (Hospital) - Cycle 10 | 2.10 units on a scale | Standard Deviation 2.57 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Breath shortness- SC (Hospital) - Cycle 10 | 1.29 units on a scale | Standard Deviation 1.88 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Remembering thing- SC (Hospital) - Cycle 10 | 2.01 units on a scale | Standard Deviation 2.21 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Lack of appetite- SC (Hospital) - Cycle 10 | 0.81 units on a scale | Standard Deviation 1.67 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Drowsy- SC (Hospital) - Cycle 10 | 2.32 units on a scale | Standard Deviation 2.52 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Dry mouth- SC (Hospital) - Cycle 10 | 1.42 units on a scale | Standard Deviation 2.06 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Feeling sad- SC (Hospital) - Cycle 10 | 1.87 units on a scale | Standard Deviation 2.38 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Vomiting- SC (Hospital) - Cycle 10 | 0.26 units on a scale | Standard Deviation 0.81 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Numbness- SC (Hospital) - Cycle 10 | 2.73 units on a scale | Standard Deviation 2.76 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Pain- SC (Home) - Cycle 13 | 1.54 units on a scale | Standard Deviation 2.33 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Fatigue- SC (Home) - Cycle 13 | 3.42 units on a scale | Standard Deviation 2.27 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Nausea- SC (Home) - Cycle 13 | 0.45 units on a scale | Standard Deviation 1.25 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Disturbed Sleep- SC (Home) - Cycle 13 | 2.63 units on a scale | Standard Deviation 2.5 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Distressed- SC (Home) - Cycle 13 | 1.81 units on a scale | Standard Deviation 2.27 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Breath shortness- SC (Home) - Cycle 13 | 1.28 units on a scale | Standard Deviation 2.06 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Remembering things- SC (Home) - Cycle 13 | 1.95 units on a scale | Standard Deviation 2.07 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Lack of appetite- SC (Home) - Cycle 13 | 0.43 units on a scale | Standard Deviation 1.29 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Drowsy- SC (Home) - Cycle 13 | 1.87 units on a scale | Standard Deviation 2.26 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Dry mouth- SC (Home) - Cycle 13 | 1.57 units on a scale | Standard Deviation 2.3 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Feeling sad- SC (Home) - Cycle 13 | 1.80 units on a scale | Standard Deviation 2.32 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Vomiting- SC (Home) - Cycle 13 | 0.22 units on a scale | Standard Deviation 1.16 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Numbness- SC (Home) - Cycle 13 | 2.51 units on a scale | Standard Deviation 2.64 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Pain- SC (Home) - Cycle 16 | 1.49 units on a scale | Standard Deviation 2.06 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Fatigue- SC (Home) - Cycle 16 | 2.79 units on a scale | Standard Deviation 2.05 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Nausea- SC (Home) - Cycle 16 | 0.57 units on a scale | Standard Deviation 1.35 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Disturbed Sleep- SC (Home) - Cycle 16 | 2.11 units on a scale | Standard Deviation 2.28 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Distressed- SC (Home) - Cycle 16 | 2.01 units on a scale | Standard Deviation 2.33 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Breath shortness- SC (Home) - Cycle 16 | 1.38 units on a scale | Standard Deviation 2.05 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Remembering things- SC (Home) - Cycle 16 | 2.14 units on a scale | Standard Deviation 2.12 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Lack of appetite- SC (Home) - Cycle 16 | 0.71 units on a scale | Standard Deviation 1.63 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Drowsy- SC (Home) - Cycle 16 | 1.74 units on a scale | Standard Deviation 2.01 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Dry mouth- SC (Home) - Cycle 16 | 1.39 units on a scale | Standard Deviation 1.93 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Feeling sad- SC (Home) - Cycle 16 | 1.98 units on a scale | Standard Deviation 2.24 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Vomiting- SC (Home) - Cycle 16 | 0.14 units on a scale | Standard Deviation 0.61 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Numbness- SC (Home) - Cycle 16 | 2.00 units on a scale | Standard Deviation 2.29 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Pain- IV (Hospital) - Cycle 7 | 1.79 units on a scale | Standard Deviation 2.51 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Fatigue- IV (Hospital) - Cycle 7 | 3.76 units on a scale | Standard Deviation 2.69 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Nausea- IV (Hospital) - Cycle 7 | 0.82 units on a scale | Standard Deviation 1.96 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Disturbed Sleep- IV (Hospital) - Cycle 7 | 3.01 units on a scale | Standard Deviation 2.89 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Distressed- IV (Hospital) - Cycle 7 | 1.99 units on a scale | Standard Deviation 2.27 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Breath shortness- IV (Hospital) - Cycle 7 | 1.59 units on a scale | Standard Deviation 2.13 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Remembering things-IV (Hospital) - Cycle 7 | 1.97 units on a scale | Standard Deviation 2.32 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Lack of appetite-IV (Hospital) - Cycle 7 | 0.85 units on a scale | Standard Deviation 1.8 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Drowsy- IV (Hospital) - Cycle 7 | 2.25 units on a scale | Standard Deviation 2.54 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Dry mouth- IV (Hospital) - Cycle 7 | 1.89 units on a scale | Standard Deviation 2.51 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Feeling sad- IV (Hospital) - Cycle 7 | 1.90 units on a scale | Standard Deviation 2.26 |
| Trastuzumab | Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire | Vomiting- IV (Hospital) - Cycle 7 | 0.34 units on a scale | Standard Deviation 1.31 |