Trial Outcomes & Findings for A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (NCT NCT05415215)
NCT ID: NCT05415215
Last Updated: 2026-01-12
Results Overview
The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV. Participants completed the PPQ, where Question (Q) 1 was: "All things considered, which setting for your treatment did you prefer?" Participants were required to select one of the following options: home, hospital or no preference. The reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting. Percentages were rounded off.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
346 participants
Primary outcome timeframe
Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)
Results posted on
2026-01-12
Participant Flow
A total of 347 participants (1 participant was re-randomized to the same PH FDC SC arm) with early or locally advanced or inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer took part in the study at 45 investigative sites across 17 countries. The study is still ongoing. The health care professionals (HCPs) treating the participants were not enrolled in the study. The HCPs only completed the HCP questionnaire (HCPQ).
Participants in Neoadjuvant Phase (NP) received either pertuzumab \& trastuzumab intravenously (P+H IV) or as a fixed-dose combination, subcutaneously (PH FDC SC), along with chemotherapy. Participants who completed NP, underwent surgical resection \& achieved pCR entered Adjuvant Phase to receive PH FDC SC in a run-in period, followed by a cross-over period \& then a continuation period at home/hospital. Participants who had residual disease after surgery received trastuzumab emtansine IV.
Participant milestones
| Measure |
Arm D, Adjuvant Continuation Phase: PH FDC SC
Participants randomized to Arm D and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm E, Adjuvant Phase: Trastuzumab Emtansine IV
Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 90 minutes as an initial dose. Thereafter, participants received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).
|
Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home
Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).
|
Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital
Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).
|
Arm C, Adjuvant Continuation Phase: PH FDC SC
Participants randomized to Arm C and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting with maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm A, Neoadjuvant Phase: P+H IV
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm B, Neoadjuvant Phase: PH FDC SC
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Adjuvant Run-in Phase: PH FDC SC in Hospital
Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Neoadjuvant Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
116
|
231
|
0
|
|
Neoadjuvant Phase
Neoadjuvant Safety Analysis Set (SASab)
|
0
|
0
|
0
|
0
|
0
|
115
|
228
|
0
|
|
Neoadjuvant Phase
Completed Neoadjuvant Treatment
|
0
|
0
|
0
|
0
|
0
|
114
|
210
|
0
|
|
Neoadjuvant Phase
Completed Surgery
|
0
|
0
|
0
|
0
|
0
|
113
|
207
|
0
|
|
Neoadjuvant Phase
Continued Into the Run-in Period
|
0
|
0
|
0
|
0
|
0
|
68
|
126
|
0
|
|
Neoadjuvant Phase
Continued Into Trastuzumab Emtansine IV Arm
|
0
|
0
|
0
|
0
|
0
|
43
|
74
|
0
|
|
Neoadjuvant Phase
Switched From IV to SC Treatment
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Neoadjuvant Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
111
|
200
|
0
|
|
Adjuvant Phase: Continuation Period
NOT COMPLETED
|
12
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
|
Neoadjuvant Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
5
|
31
|
0
|
|
Adjuvant Phase: Run-in Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
194
|
|
Adjuvant Phase: Run-in Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
194
|
|
Adjuvant Phase: Run-in Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
STARTED
|
0
|
0
|
98
|
96
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
Received ≥1 Dose of Adjuvant Cross-Over Treatment
|
0
|
0
|
97
|
96
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
COMPLETED
|
0
|
0
|
96
|
93
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
NOT COMPLETED
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
STARTED
|
93
|
0
|
0
|
0
|
96
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Chose Home Setting for Continuation Treatment
|
50
|
0
|
0
|
0
|
66
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Chose Hospital Setting for Continuation Treatment
|
42
|
0
|
0
|
0
|
30
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Received ≥1 Dose of Continuation Treatment
|
89
|
0
|
0
|
0
|
96
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
COMPLETED
|
81
|
0
|
0
|
0
|
82
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
STARTED
|
0
|
117
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
COMPLETED
|
0
|
77
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
NOT COMPLETED
|
0
|
40
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
STARTED
|
87
|
87
|
0
|
0
|
85
|
0
|
0
|
0
|
|
Follow-up Period
COMPLETED
|
40
|
34
|
0
|
0
|
40
|
0
|
0
|
0
|
|
Follow-up Period
NOT COMPLETED
|
47
|
53
|
0
|
0
|
45
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm D, Adjuvant Continuation Phase: PH FDC SC
Participants randomized to Arm D and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm E, Adjuvant Phase: Trastuzumab Emtansine IV
Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 90 minutes as an initial dose. Thereafter, participants received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).
|
Arm C, Adjuvant Cross-over Phase: PH FDC SC in Hospital, Then at Home
Participants who completed the run-in period and were randomized to Arm C received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the hospital setting, followed by 3 cycles in the home setting (Cycle length = 21 days).
|
Arm D, Adjuvant Cross-Over Phase: PH FDC SC at Home, Then in Hospital
Participants who completed the run-in period and were randomized to Arm D received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for the first 3 cycles in the home setting, followed by 3 cycles in the hospital setting (Cycle length = 21 days).
|
Arm C, Adjuvant Continuation Phase: PH FDC SC
Participants randomized to Arm C and who completed the cross-over period had an option to receive further treatment in either the home or hospital setting with maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm A, Neoadjuvant Phase: P+H IV
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm B, Neoadjuvant Phase: PH FDC SC
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Adjuvant Run-in Phase: PH FDC SC in Hospital
Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Neoadjuvant Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
|
Neoadjuvant Phase
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Neoadjuvant Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
11
|
0
|
|
Neoadjuvant Phase
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Neoadjuvant Phase
Reason not Specified
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
|
Neoadjuvant Phase
Treatment Intolerance
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Neoadjuvant Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Adjuvant Phase: Cross-over Period
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Cross-over Period
Treatment Intolerance
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Non-compliance With Study Drug
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Progressive Disease
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Reason not Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Continuation Period
Ongoing in Treatment
|
9
|
0
|
0
|
0
|
11
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Adverse Event
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Reason not Specified
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Treatment intolerance
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Adjuvant Phase: Trastuzumab Emtansine IV
Ongoing in Treatment
|
0
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Ongoing in Follow-up
|
45
|
51
|
0
|
0
|
44
|
0
|
0
|
0
|
|
Follow-up Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A, Neoadjuvant Phase: P+H IV
n=116 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm B, Neoadjuvant Phase: PH FDC SC
n=231 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Total
n=347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 11.0 • n=210 Participants
|
52.9 years
STANDARD_DEVIATION 11.7 • n=19 Participants
|
52.2 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=210 Participants
|
230 Participants
n=19 Participants
|
346 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=210 Participants
|
93 Participants
n=19 Participants
|
145 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=210 Participants
|
118 Participants
n=19 Participants
|
172 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=210 Participants
|
20 Participants
n=19 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=210 Participants
|
35 Participants
n=19 Participants
|
50 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=210 Participants
|
32 Participants
n=19 Participants
|
44 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=210 Participants
|
23 Participants
n=19 Participants
|
33 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=210 Participants
|
123 Participants
n=19 Participants
|
189 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=210 Participants
|
13 Participants
n=19 Participants
|
23 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)Population: Adjuvant cross-over modified intent-to-treat (mITTcross) population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ, and completed radiotherapy before entering the cross-over period.
The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV. Participants completed the PPQ, where Question (Q) 1 was: "All things considered, which setting for your treatment did you prefer?" Participants were required to select one of the following options: home, hospital or no preference. The reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=83 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=87 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)
No Preference
|
1.2 percentage of participants
|
8.0 percentage of participants
|
|
Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)
Home
|
59.0 percentage of participants
|
69.0 percentage of participants
|
|
Cross-over Period: Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in Question 1 of the Patient Preference Questionnaire (PPQ)
Hospital
|
39.8 percentage of participants
|
23.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1-8 (Cycle length = 21 days)Population: Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion. Overall number analyzed is the number of HCPs who answered Q1a of the HCPQ. Number analyzed is the number of HCPs who answered Q1a of the HCPQ at the specified time point.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1a: "Please indicate which treatment preparation the estimates relate to". HCPs were required to select one of the following options: PH FDC SC or P+H IV. The response to Q1a was used to further assess Q1b: How long did it take to prepare the treatment for use? Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=211 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=113 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 2 Day 1: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 1 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 1 Day 1: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 2 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 3 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 3 Day 1: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 4 Day 1: PH FDC SC
|
100 percentage of HCPs
|
1.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 4 Day 1: P+H IV
|
0 percentage of HCPs
|
98.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 5 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 5 Day 1: P+H IV
|
0 percentage of HCPs
|
99.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 6 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 6 Day 1: P+H IV
|
0 percentage of HCPs
|
99.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 7 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 7 Day 1: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 8 Day 1: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 1a of HCPQ - Drug Preparation Area
Cycle 8 Day 1: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1-8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ. Number analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified time point.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question of the HCPQ: Q1b: "How long did it take to prepare the treatment for use?" This was a follow up question to Q1a: "Please indicate which treatment preparation the estimates relate to" for which HCPs were required to select one of the following options: PH FDC SC or P+H IV.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=211 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=113 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 1 Day 1
|
5.0 minutes
Interval 0.0 to 30.0
|
20.0 minutes
Interval 1.0 to 120.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 2 Day 1
|
5.0 minutes
Interval 0.0 to 40.0
|
20.5 minutes
Interval 1.0 to 50.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 3 Day 1
|
5.0 minutes
Interval 1.0 to 35.0
|
20.0 minutes
Interval 1.0 to 50.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 4 Day 1
|
5.0 minutes
Interval 1.0 to 30.0
|
20.0 minutes
Interval 1.0 to 50.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 5 Day 1
|
5.0 minutes
Interval 1.0 to 52.0
|
20.0 minutes
Interval 1.0 to 110.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 6 Day 1
|
5.0 minutes
Interval 1.0 to 131.0
|
20.0 minutes
Interval 1.0 to 410.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 7 Day 1
|
4.0 minutes
Interval 1.0 to 45.0
|
13.5 minutes
Interval 4.0 to 90.0
|
|
Neoadjuvant Phase: Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1b of HCPQ - Drug Preparation Area
Cycle 8 Day 1
|
5.0 minutes
Interval 1.0 to 45.0
|
15.0 minutes
Interval 4.0 to 90.0
|
SECONDARY outcome
Timeframe: Up to Day 1 of Cycle 8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ. Number analyzed is the number of HCPs who responded to each sub-question of Q2 (Q2a-Q2g) of the HCPQ.
HCP=any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation of P+H IV and/or administration of PH FDC SC completed the following question 2 of the HCPQs: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Staff will have increased availability for other tasks in the pharmacy. 2b: Administrative procedures related to PH FDC SC require less time. 2c: Using PH FDC SC provides more flexibility for pharmacy staff in managing their workload. 2d: As PH FDC SC is fixed-dose, potential dosing errors are avoided. 2e: As PH FDC SC is fixed-dose, there is less drug wastage. 2f: Less storage space for PH FDC SC-related supplies is required in the pharmacy, as there is no need for reconstitution. 2g: Number of preparation steps \& staff time commitment are reduced. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=165 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=89 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Strongly Disagree
|
2.4 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Disagree
|
2.4 percentage of HCPs
|
3.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Neutral
|
11.0 percentage of HCPs
|
13.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Agree
|
38.4 percentage of HCPs
|
25.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Strongly Agree
|
39.6 percentage of HCPs
|
52.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2a: Not Applicable
|
6.1 percentage of HCPs
|
3.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Strongly Disagree
|
2.4 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Disagree
|
15.2 percentage of HCPs
|
12.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Neutral
|
14.6 percentage of HCPs
|
13.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Agree
|
25.6 percentage of HCPs
|
18.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Strongly Agree
|
35.4 percentage of HCPs
|
47.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2b: Not Applicable
|
6.7 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Strongly Disagree
|
1.2 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Disagree
|
2.4 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Neutral
|
14.0 percentage of HCPs
|
11.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Agree
|
41.5 percentage of HCPs
|
28.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Strongly Agree
|
34.1 percentage of HCPs
|
50.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2c: Not Applicable
|
6.7 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Strongly Disagree
|
1.2 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Disagree
|
2.4 percentage of HCPs
|
2.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Neutral
|
7.9 percentage of HCPs
|
2.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Agree
|
36.0 percentage of HCPs
|
28.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Strongly Agree
|
46.3 percentage of HCPs
|
61.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2d: Not Applicable
|
6.1 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Strongly Disagree
|
1.2 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Disagree
|
3.7 percentage of HCPs
|
3.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Neutral
|
6.1 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Strongly Agree
|
35.4 percentage of HCPs
|
31.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Agree
|
47.6 percentage of HCPs
|
58.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2e: Not Available
|
6.1 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Strongly Disagree
|
1.2 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Disagree
|
6.1 percentage of HCPs
|
5.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Neutral
|
12.2 percentage of HCPs
|
10.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Strongly Agree
|
33.5 percentage of HCPs
|
24.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Agree
|
40.9 percentage of HCPs
|
53.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2f: Not available
|
6.1 percentage of HCPs
|
4.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Strongly Disagree
|
1.8 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Disagree
|
4.2 percentage of HCPs
|
7.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Neutral
|
6.1 percentage of HCPs
|
7.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Strongly Agree
|
36.4 percentage of HCPs
|
23.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Agree
|
44.8 percentage of HCPs
|
56.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 of the HCPQ - Drug Preparation Area
Q2g: Not available
|
6.7 percentage of HCPs
|
3.4 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1-8 (Cycle length = 21 days)Population: Participants could have changed from P+H IV treatment to PH FDC SC treatment, in exceptional circumstances and at the investigator discretion. Overall number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ. Number analyzed is the number of HCPs who answered Q1a to Q1e of the HCPQ at the specified time point.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1a: Please indicate which treatment preparation the estimates relate to. Q1b: Did the participant have existing IV access? Q1c: If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided. Q1d: What type of existing IV access did the participant have? Q1e: When did the existing IV access place? Percentages were rounded off. PICC = peripherally inserted central catheter.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=213 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=112 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1c: Central Venous Catheter
|
0 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1d: Central Venous Catheter
|
0 percentage of HCPs
|
10.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1d: PICC
|
100 percentage of HCPs
|
47.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1d: Port-a-Cath
|
0 percentage of HCPs
|
31.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
10.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1e: Within 7 Days Prior Today
|
14.3 percentage of HCPs
|
20.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1e: > 7 < 14 Days Prior Today
|
28.6 percentage of HCPs
|
13.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1e: > 14 < 30 Days Prior Today
|
0 percentage of HCPs
|
20.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1e: Other
|
57.1 percentage of HCPs
|
46.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1b: Yes
|
0 percentage of HCPs
|
24.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1b: No
|
100 percentage of HCPs
|
75.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1c: Peripheral Vein Cannulation
|
100 percentage of HCPs
|
90.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1c: Central Venous Catheter
|
0 percentage of HCPs
|
9.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1d: Central Venous Catheter
|
0 percentage of HCPs
|
40.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1d: PICC
|
50.0 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1d: Port-a-Cath
|
50.0 percentage of HCPs
|
26.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1e: Within 7 Days Prior Today
|
16.7 percentage of HCPs
|
50.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1e: > 7 < 14 Days Prior Today
|
33.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1e: > 14 < 30 Days Prior Today
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1e: Other
|
50.0 percentage of HCPs
|
50.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1b: Yes
|
60.0 percentage of HCPs
|
23.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1b: No
|
40.0 percentage of HCPs
|
77.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1c: Peripheral Vein Cannulation
|
66.7 percentage of HCPs
|
88.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1c: Central Venous Catheter
|
33.3 percentage of HCPs
|
11.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1d: Central Venous Catheter
|
40.0 percentage of HCPs
|
35.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1d: PICC
|
20.0 percentage of HCPs
|
28.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1d: Port-a-Cath
|
40.0 percentage of HCPs
|
35.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1e: Within 7 Days Prior Today
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1e: > 7 < 14 Days Prior Today
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1e: > 14 < 30 Days Prior Today
|
62.5 percentage of HCPs
|
16.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1e: Other
|
37.5 percentage of HCPs
|
83.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1b: Yes
|
100 percentage of HCPs
|
26.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1b: No
|
0 percentage of HCPs
|
73.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1c: Peripheral Vein Cannulation
|
100 percentage of HCPs
|
88.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
2.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1c: Central Venous Catheter
|
0 percentage of HCPs
|
9.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1d: Central Venous Catheter
|
57.1 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1d: PICC
|
28.6 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1d: Port-a-Cath
|
14.3 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1e: Within 7 Days Prior Today
|
16.7 percentage of HCPs
|
16.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1e: > 7 < 14 Days Prior Today
|
8.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1e: > 14 < 30 Days Prior Today
|
25.0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1e: Other
|
50.0 percentage of HCPs
|
83.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
1.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
98.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1b: Yes
|
50.0 percentage of HCPs
|
32.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1b: No
|
50.0 percentage of HCPs
|
67.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1c: Peripheral Vein Cannulation
|
50.0 percentage of HCPs
|
89.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1c: Central Venous Catheter
|
50.0 percentage of HCPs
|
10.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1d: Central Venous Catheter
|
50.0 percentage of HCPs
|
30.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1d: PICC
|
0 percentage of HCPs
|
35.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1d: Port-a-Cath
|
50.0 percentage of HCPs
|
35.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1e: Within 7 Days Prior Today
|
7.7 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1e: > 7 < 14 Days Prior Today
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1e: > 14 < 30 Days Prior Today
|
38.5 percentage of HCPs
|
14.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1e: Other
|
53.8 percentage of HCPs
|
85.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
99.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1b: Yes
|
25.0 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1b: No
|
75.0 percentage of HCPs
|
66.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1c: Port-a-cath
|
0 percentage of HCPs
|
1.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1c: Peripheral Vein Cannulation
|
83.3 percentage of HCPs
|
93.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1e: Other
|
51.9 percentage of HCPs
|
52.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1c: Central Venous Catheter
|
16.7 percentage of HCPs
|
5.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1d: Central Venous Catheter
|
16.7 percentage of HCPs
|
19.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1d: PICC
|
0 percentage of HCPs
|
41.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1d: Port-a-Cath
|
83.3 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
5.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1e: Within 7 Days Prior Today
|
7.4 percentage of HCPs
|
21.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1e: > 7 < 14 Days Prior Today
|
11.1 percentage of HCPs
|
10.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1e: > 14 < 30 Days Prior Today
|
29.6 percentage of HCPs
|
15.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
99.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1b: Yes
|
40.0 percentage of HCPs
|
34.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1b: No
|
60.0 percentage of HCPs
|
65.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c: Port-a-cath
|
0 percentage of HCPs
|
2.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c: Peripheral Vein Cannulation
|
100 percentage of HCPs
|
94.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c: Central Venous Catheter
|
0 percentage of HCPs
|
2.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1d: Central Venous Catheter
|
0 percentage of HCPs
|
16.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1d: PICC
|
14.3 percentage of HCPs
|
43.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1d: Port-a-Cath
|
85.7 percentage of HCPs
|
32.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
8.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1e: Within 7 Days Prior Today
|
6.5 percentage of HCPs
|
25.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1e: > 7 < 14 Days Prior Today
|
9.7 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1e: > 14 < 30 Days Prior Today
|
29.0 percentage of HCPs
|
15.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1e: Other
|
54.8 percentage of HCPs
|
60.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1b: Yes
|
66.7 percentage of HCPs
|
28.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1b: No
|
33.3 percentage of HCPs
|
71.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1c: Peripheral Vein Cannulation
|
50.0 percentage of HCPs
|
97.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1c: Central Venous Catheter
|
50.0 percentage of HCPs
|
2.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1d: Central Venous Catheter
|
0 percentage of HCPs
|
6.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1d: PICC
|
20.0 percentage of HCPs
|
50.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1d: Port-a-Cath
|
80.0 percentage of HCPs
|
25.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1d: Tunneled Central Venous Catheter
|
0 percentage of HCPs
|
18.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1e: Within 7 Days Prior Today
|
11.8 percentage of HCPs
|
38.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1e: > 7 < 14 Days Prior Today
|
17.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1e: > 14 < 30 Days Prior Today
|
5.9 percentage of HCPs
|
15.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1e: Other
|
64.7 percentage of HCPs
|
46.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1a: PH FDC SC
|
100 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1a: P+H IV
|
0 percentage of HCPs
|
100 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1b: Yes
|
0 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1b: No
|
100 percentage of HCPs
|
66.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1c: Peripheral Vein Cannulation
|
100 percentage of HCPs
|
97.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Questions 1a-1e of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1c: PICC
|
0 percentage of HCPs
|
0 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1-8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ. Number analyzed is the number of HCPs who answered Q1c, Q1f and Q1g of the HCPQ at the specified time point.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with administration of P+H IV and/or PH FDC SC completed the following Questions of the HCPQ: Q1c: If new IV access was needed for this cycle of treatment, how long (in minutes) this took to set up? Q1f: How long (in minutes) did it take to administer the treatment (P+H IV or PH FDC SC)? Q1g: How long (in minutes) was the participant in the Treatment Area in total? Percentages have been rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=212 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=112 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1c
|
5.0 minutes
Interval 4.0 to 8.0
|
5.0 minutes
Interval 1.0 to 20.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1f
|
5.0 minutes
Interval 5.0 to 190.0
|
82.5 minutes
Interval 5.0 to 360.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1c
|
5.0 minutes
Interval 1.0 to 308.0
|
5.0 minutes
Interval 1.0 to 150.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1f
|
8.0 minutes
Interval 5.0 to 30.0
|
180.0 minutes
Interval 60.0 to 390.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 1 Day 1: Q1g
|
180.0 minutes
Interval 8.0 to 424.0
|
420.0 minutes
Interval 120.0 to 520.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1c
|
5.0 minutes
Interval 2.0 to 6.0
|
5.0 minutes
Interval 1.0 to 18.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 2 Day 1: Q1g
|
180.0 minutes
Interval 5.0 to 330.0
|
300.0 minutes
Interval 90.0 to 503.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1c
|
10.0 minutes
Interval 5.0 to 10.0
|
5.0 minutes
Interval 1.0 to 20.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1f
|
5.0 minutes
Interval 3.0 to 159.0
|
90.0 minutes
Interval 5.0 to 360.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1g
|
180.0 minutes
Interval 6.0 to 480.0
|
280.0 minutes
Interval 90.0 to 500.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1c
|
6.5 minutes
Interval 5.0 to 10.0
|
5.0 minutes
Interval 2.0 to 20.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1f
|
5.0 minutes
Interval 3.0 to 15.0
|
90.0 minutes
Interval 14.0 to 365.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 4 Day 1: Q1g
|
170.0 minutes
Interval 6.0 to 480.0
|
270.0 minutes
Interval 30.0 to 560.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1c
|
5.0 minutes
Interval 1.0 to 10.0
|
5.0 minutes
Interval 1.0 to 150.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1f
|
8.0 minutes
Interval 4.0 to 250.0
|
145.0 minutes
Interval 8.0 to 360.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 5 Day 1: Q1g
|
150.0 minutes
Interval 5.0 to 420.0
|
294.0 minutes
Interval 30.0 to 552.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c
|
5.0 minutes
Interval 2.0 to 5.0
|
5.0 minutes
Interval 1.0 to 25.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1f
|
5.0 minutes
Interval 4.0 to 80.0
|
90.0 minutes
Interval 8.0 to 360.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1g
|
150.0 minutes
Interval 5.0 to 370.0
|
260.0 minutes
Interval 35.0 to 510.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1c
|
3.0 minutes
Interval 3.0 to 3.0
|
5.0 minutes
Interval 1.0 to 30.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1f
|
5.0 minutes
Interval 4.0 to 75.0
|
90.0 minutes
Interval 8.0 to 210.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 7 Day 1: Q1g
|
115.0 minutes
Interval 5.0 to 360.0
|
190.0 minutes
Interval 40.0 to 480.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1f
|
5.0 minutes
Interval 3.0 to 25.0
|
90.0 minutes
Interval 5.0 to 180.0
|
|
Neoadjuvant Phase: Duration of Treatment Administration According to HCPs' Responses to Questions 1c (Sub-part), 1f, and 1g of the HCPQ - Administering Treatment
Cycle 8 Day 1: Q1g
|
120.0 minutes
Interval 6.0 to 345.0
|
180.0 minutes
Interval 60.0 to 535.0
|
SECONDARY outcome
Timeframe: Up to Cycle 8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any sub part Q2 (2a to 2e) of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (2a to 2e) of the HCPQ.
HCP was defined as any personnel involved in the drug preparation \&/or drug administration processes. HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Q2 (2a-2e) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2a: Participants may be moved out of the Treatment Area (for infusion treatment) to receive PH FDC SC injections. 2b: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2c: Frees up infusion chairs for participants whose treatments can only be given IV. 2d: Waiting list for any P+H IV treatment at the Treatment Area is reduced. 2e: Staff's work burden is reduced, enhancing work performance. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=166 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=98 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Strongly Disagree
|
3.0 percentage of HCPs
|
1.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Disagree
|
13.4 percentage of HCPs
|
8.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Neutral
|
13.4 percentage of HCPs
|
14.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Agree
|
28.7 percentage of HCPs
|
36.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Strongly Agree
|
33.5 percentage of HCPs
|
32.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2a: Not Applicable
|
7.9 percentage of HCPs
|
8.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Strongly Disagree
|
2.4 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Disagree
|
6.0 percentage of HCPs
|
9.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Neutral
|
13.9 percentage of HCPs
|
12.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Agree
|
34.3 percentage of HCPs
|
37.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Strongly Agree
|
35.5 percentage of HCPs
|
33.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2b: Not Applicable
|
7.8 percentage of HCPs
|
7.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Strongly Disagree
|
3.0 percentage of HCPs
|
1.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Disagree
|
6.0 percentage of HCPs
|
9.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Neutral
|
10.8 percentage of HCPs
|
10.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Agree
|
35.5 percentage of HCPs
|
32.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Strongly Agree
|
37.3 percentage of HCPs
|
39.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2c: Not Applicable
|
7.2 percentage of HCPs
|
7.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Strongly Disagree
|
1.8 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Disagree
|
6.0 percentage of HCPs
|
8.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Neutral
|
15.7 percentage of HCPs
|
15.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Agree
|
37.3 percentage of HCPs
|
34.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Strongly Agree
|
31.9 percentage of HCPs
|
35.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2d: Not Applicable
|
7.2 percentage of HCPs
|
6.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Strongly Disagree
|
3.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Disagree
|
3.6 percentage of HCPs
|
5.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Neutral
|
25.5 percentage of HCPs
|
27.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Agree
|
27.3 percentage of HCPs
|
26.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Strongly Agree
|
32.7 percentage of HCPs
|
34.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Response to Question 2 (2a to 2e) of the HCPQ - Administering Treatment
Q2e: Not Applicable
|
7.3 percentage of HCPs
|
6.1 percentage of HCPs
|
SECONDARY outcome
Timeframe: Up to Cycle 8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any sub part of Q2 (2f to 2j) of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (2f to 2j) of the HCPQ.
HCP was defined as any personnel involved in the drug preparation \&/or drug administration processes. HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Question 2 (2f to 2j) of the HCPQ: In your opinion, if all P+H IV infusions were switched to PH FDC SC injections, please indicate how strongly you agree/disagree with each of the following statements. 2f: More interaction time between HCPs and participants. 2g: Staff have more time for further professional education/development. 2h: Staff has more time for administrative tasks. 2i: Participants on PH FDC SC spend less time in the Treatment Area. 2j: Participants prefer PH FDC SC to P+H IV. The 6 available options were: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree and Not applicable. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=166 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=98 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Strongly Disagree
|
2.4 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Disagree
|
4.2 percentage of HCPs
|
8.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Neutral
|
34.3 percentage of HCPs
|
20.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Agree
|
22.3 percentage of HCPs
|
33.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Strongly Agree
|
28.9 percentage of HCPs
|
31.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2f: Not Applicable
|
7.8 percentage of HCPs
|
6.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Strongly Disagree
|
2.4 percentage of HCPs
|
2.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Disagree
|
4.8 percentage of HCPs
|
5.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Neutral
|
36.7 percentage of HCPs
|
25.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Agree
|
22.9 percentage of HCPs
|
31.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Strongly Agree
|
25.3 percentage of HCPs
|
29.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2g: Not Applicable
|
7.8 percentage of HCPs
|
6.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Strongly Disagree
|
1.2 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Disagree
|
3.6 percentage of HCPs
|
6.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Neutral
|
31.9 percentage of HCPs
|
23.5 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Agree
|
25.9 percentage of HCPs
|
30.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Strongly Agree
|
28.9 percentage of HCPs
|
33.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2h: Not Applicable
|
8.4 percentage of HCPs
|
6.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Strongly Disagree
|
1.8 percentage of HCPs
|
1.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Disagree
|
1.8 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Neutral
|
3.0 percentage of HCPs
|
4.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Agree
|
31.9 percentage of HCPs
|
26.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Strongly Agree
|
53.0 percentage of HCPs
|
61.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2i: Not Applicable
|
8.4 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Strongly Disagree
|
0.6 percentage of HCPs
|
1.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Disagree
|
1.8 percentage of HCPs
|
1.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Neutral
|
21.7 percentage of HCPs
|
20.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Agree
|
31.3 percentage of HCPs
|
35.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Strongly Agree
|
32.5 percentage of HCPs
|
35.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 2 (2f to 2j) of the HCPQ - Administering Treatment
Q2j: Not Applicable
|
12.0 percentage of HCPs
|
7.2 percentage of HCPs
|
SECONDARY outcome
Timeframe: Up to Cycle 8 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q11 of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q3 to Q11) of the HCPQ.
HCPs who have had experience with administration of P+H IV \&/or PH FDC SC completed Questions 3 to 11 of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care at your institution? Q5: Which required less time to administer (excluding observation period)? Q6: Which required less use of institutional resources (e.g., staff time, facility costs, equipment use)? Q7: Which required less time to administer all the treatment (including IV chemotherapy)? Q8: Which allowed for attending to more participants because of time savings from the mode of administration of pertuzumab and trastuzumab? Q9: During the NP you had to administer IV chemotherapy through participant's IV access. You prefer to accompany IV chemotherapy with? Q10: Which was preferred by participants? Q11: How frequently would you recommend PH FDC SC administration to your participants in the future? Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=166 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=98 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q3: P+H IV
|
1.2 percentage of HCPs
|
8.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q3: PH FDC SC
|
83.9 percentage of HCPs
|
68.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q3: No Difference
|
8.7 percentage of HCPs
|
13.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q3: Unsure
|
6.2 percentage of HCPs
|
10.2 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q4: P+H IV
|
1.9 percentage of HCPs
|
5.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q4: PH FDC SC
|
82.1 percentage of HCPs
|
69.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q4: No Difference
|
13.0 percentage of HCPs
|
22.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q4: Unsure
|
3.1 percentage of HCPs
|
2.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q5: P+H IV
|
0.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q5: PH FDC SC
|
97.5 percentage of HCPs
|
92.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q5: No Difference
|
1.9 percentage of HCPs
|
8.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q5: Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q6: P+H IV
|
0.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q6: PH FDC SC
|
88.9 percentage of HCPs
|
83.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q6: No Difference
|
10.5 percentage of HCPs
|
17.0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q6: Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q7: P+H IV
|
0 percentage of HCPs
|
1.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q7: PH FDC SC
|
98.1 percentage of HCPs
|
96.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q7: No Difference
|
1.9 percentage of HCPs
|
2.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q7: Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q8: P+H IV
|
0.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q8: PH FDC SC
|
82.7 percentage of HCPs
|
73.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q8: No Difference
|
16.7 percentage of HCPs
|
26.4 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q8: Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q9: P+H IV
|
8.7 percentage of HCPs
|
12.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q9: PH FDC SC
|
73.9 percentage of HCPs
|
73.6 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q9: No Difference
|
17.4 percentage of HCPs
|
13.8 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q9: Unsure
|
0 percentage of HCPs
|
0 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q10: P+H IV
|
1.2 percentage of HCPs
|
7.9 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q10: PH FDC SC
|
73.5 percentage of HCPs
|
66.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q10: No Difference
|
7.4 percentage of HCPs
|
10.1 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q10: Unsure
|
17.9 percentage of HCPs
|
15.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q11: Always
|
79.1 percentage of HCPs
|
75.3 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q11: Sometimes
|
19.0 percentage of HCPs
|
24.7 percentage of HCPs
|
|
Neoadjuvant Phase: Percentage of HCPs by Their Responses to Question 3 to 11 of the HCPQ - Administering Treatment
Q11: Never
|
1.9 percentage of HCPs
|
0 percentage of HCPs
|
SECONDARY outcome
Timeframe: Up to approximately 7.8 monthsPopulation: FASab included all randomized participants, regardless of whether they received treatment. Overall number analyzed is the number of participants with data available for analysis.
pCR was defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0), according to the current American Joint Committee on Cancer (AJCC) staging system classification. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=207 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=113 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Percentage of Participants Who Achieved pCR Post-surgery
|
60.9 percentage of participants
|
60.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 6 and 8 (Cycle length = 21 days)Population: FASab included all randomized participants, regardless of whether they received treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), global health status/quality of life (GHS/QoL) \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=223 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=115 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - GHS/QoL
|
75.97 score on a scale
Standard Deviation 20.92
|
79.86 score on a scale
Standard Deviation 18.40
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - GHS/QoL
|
-7.40 score on a scale
Standard Deviation 24.64
|
-9.43 score on a scale
Standard Deviation 21.27
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - GHS/QoL
|
-11.75 score on a scale
Standard Deviation 26.78
|
-10.42 score on a scale
Standard Deviation 19.73
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Physical functioning (PF)
|
91.84 score on a scale
Standard Deviation 12.45
|
91.65 score on a scale
Standard Deviation 11.84
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - PF
|
-16.01 score on a scale
Standard Deviation 18.56
|
-12.65 score on a scale
Standard Deviation 16.18
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - PF
|
-13.00 score on a scale
Standard Deviation 16.25
|
-16.03 score on a scale
Standard Deviation 19.28
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Role Functioning (RF)
|
91.48 score on a scale
Standard Deviation 19.11
|
91.88 score on a scale
Standard Deviation 15.82
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - RF
|
-21.18 score on a scale
Standard Deviation 29.46
|
-15.85 score on a scale
Standard Deviation 28.78
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - RF
|
-14.91 score on a scale
Standard Deviation 27.98
|
-19.87 score on a scale
Standard Deviation 27.62
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Emotional Functioning (EF)
|
71.45 score on a scale
Standard Deviation 22.54
|
73.41 score on a scale
Standard Deviation 22.13
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - EF
|
1.01 score on a scale
Standard Deviation 25.20
|
-5.87 score on a scale
Standard Deviation 26.06
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - EF
|
5.85 score on a scale
Standard Deviation 25.01
|
5.29 score on a scale
Standard Deviation 24.09
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Cognitive functioning (CF)
|
88.19 score on a scale
Standard Deviation 17.62
|
88.41 score on a scale
Standard Deviation 19.01
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - CF
|
-10.28 score on a scale
Standard Deviation 23.53
|
-12.02 score on a scale
Standard Deviation 22.39
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - CF
|
-4.74 score on a scale
Standard Deviation 18.78
|
-9.62 score on a scale
Standard Deviation 25.21
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Social Functioning (SF)
|
84.30 score on a scale
Standard Deviation 24.56
|
86.67 score on a scale
Standard Deviation 22.96
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - SF
|
-15.26 score on a scale
Standard Deviation 32.55
|
-18.03 score on a scale
Standard Deviation 30.01
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - SF
|
-7.54 score on a scale
Standard Deviation 25.59
|
-14.42 score on a scale
Standard Deviation 27.82
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Fatigue
|
16.44 score on a scale
Standard Deviation 17.74
|
15.85 score on a scale
Standard Deviation 20.29
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Fatigue
|
27.21 score on a scale
Standard Deviation 25.91
|
24.04 score on a scale
Standard Deviation 26.23
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Fatigue
|
20.23 score on a scale
Standard Deviation 24.31
|
23.29 score on a scale
Standard Deviation 24.33
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Nausea & Vomiting
|
3.36 score on a scale
Standard Deviation 10.25
|
4.06 score on a scale
Standard Deviation 11.60
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Nausea & Vomiting
|
14.80 score on a scale
Standard Deviation 22.82
|
19.95 score on a scale
Standard Deviation 24.69
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Nausea & Vomiting
|
4.74 score on a scale
Standard Deviation 17.64
|
3.21 score on a scale
Standard Deviation 20.88
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Pain
|
14.13 score on a scale
Standard Deviation 19.14
|
12.17 score on a scale
Standard Deviation 18.25
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Pain
|
7.79 score on a scale
Standard Deviation 25.83
|
14.21 score on a scale
Standard Deviation 27.53
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Pain
|
8.07 score on a scale
Standard Deviation 21.59
|
11.86 score on a scale
Standard Deviation 29.21
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Dyspnoea
|
6.28 score on a scale
Standard Deviation 16.45
|
4.35 score on a scale
Standard Deviation 14.32
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Dyspnoea
|
12.46 score on a scale
Standard Deviation 24.88
|
8.74 score on a scale
Standard Deviation 23.49
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Dyspnoea
|
6.67 score on a scale
Standard Deviation 23.11
|
13.46 score on a scale
Standard Deviation 28.97
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Insomnia
|
24.51 score on a scale
Standard Deviation 28.07
|
25.22 score on a scale
Standard Deviation 30.14
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Insomnia
|
3.12 score on a scale
Standard Deviation 35.33
|
4.37 score on a scale
Standard Deviation 32.48
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Insomnia
|
9.12 score on a scale
Standard Deviation 33.84
|
8.97 score on a scale
Standard Deviation 40.75
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Appetite Loss
|
9.72 score on a scale
Standard Deviation 20.51
|
8.41 score on a scale
Standard Deviation 20.16
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Appetite Loss
|
23.99 score on a scale
Standard Deviation 33.89
|
21.31 score on a scale
Standard Deviation 32.22
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Appetite Loss
|
15.09 score on a scale
Standard Deviation 35.65
|
16.03 score on a scale
Standard Deviation 33.97
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Constipation
|
9.87 score on a scale
Standard Deviation 20.56
|
9.57 score on a scale
Standard Deviation 21.07
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Constipation
|
5.61 score on a scale
Standard Deviation 25.69
|
7.65 score on a scale
Standard Deviation 29.44
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Constipation
|
3.86 score on a scale
Standard Deviation 24.73
|
2.61 score on a scale
Standard Deviation 21.95
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Diarrhoea
|
4.93 score on a scale
Standard Deviation 14.86
|
3.77 score on a scale
Standard Deviation 13.07
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Diarrhoea
|
28.04 score on a scale
Standard Deviation 34.31
|
25.68 score on a scale
Standard Deviation 33.55
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Diarrhoea
|
27.37 score on a scale
Standard Deviation 33.68
|
32.05 score on a scale
Standard Deviation 26.37
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Baseline - Financial Difficulties
|
23.17 score on a scale
Standard Deviation 32.67
|
26.09 score on a scale
Standard Deviation 34.14
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 6 Day 1 - Financial Difficulties
|
7.79 score on a scale
Standard Deviation 35.93
|
6.01 score on a scale
Standard Deviation 41.95
|
|
Neoadjuvant Phase: Change From Baseline in Health-related Quality of Life (HRQoL) Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) Scores
Change at Cycle 8 Day 1 - Financial Difficulties
|
-1.40 score on a scale
Standard Deviation 33.66
|
6.41 score on a scale
Standard Deviation 28.80
|
SECONDARY outcome
Timeframe: Baseline (Cycle 1) of Run-in Period; Day 1 of Cycles 1, 3, and 6 in the Cross-over Period (Cycle length = 21 days)Population: mITTcross population included all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC, completed Question 1 of the PPQ and completed radiotherapy before entering the cross-over period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=96 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=98 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1- GHS/QoL
|
0.09 score on a scale
Standard Deviation 18.57
|
0.66 score on a scale
Standard Deviation 13.72
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - GHS/QoL
|
5.15 score on a scale
Standard Deviation 20.59
|
2.08 score on a scale
Standard Deviation 14.53
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - GHS/QoL
|
71.79 score on a scale
Standard Deviation 18.63
|
76.98 score on a scale
Standard Deviation 17.09
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - GHS/QoL
|
2.48 score on a scale
Standard Deviation 19.99
|
-0.57 score on a scale
Standard Deviation 16.61
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - PF
|
80.35 score on a scale
Standard Deviation 16.20
|
82.61 score on a scale
Standard Deviation 15.89
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - PF
|
1.83 score on a scale
Standard Deviation 14.44
|
2.50 score on a scale
Standard Deviation 13.19
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - PF
|
5.99 score on a scale
Standard Deviation 14.18
|
2.50 score on a scale
Standard Deviation 13.65
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - PF
|
2.46 score on a scale
Standard Deviation 14.99
|
4.13 score on a scale
Standard Deviation 16.97
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - RF
|
66.67 score on a scale
Standard Deviation 29.72
|
78.35 score on a scale
Standard Deviation 21.40
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - RF
|
10.62 score on a scale
Standard Deviation 27.84
|
4.92 score on a scale
Standard Deviation 21.61
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - RF
|
17.23 score on a scale
Standard Deviation 31.33
|
6.25 score on a scale
Standard Deviation 23.61
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - RF
|
16.07 score on a scale
Standard Deviation 31.73
|
9.66 score on a scale
Standard Deviation 23.53
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - EF
|
76.65 score on a scale
Standard Deviation 22.61
|
82.22 score on a scale
Standard Deviation 19.31
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - EF
|
0.34 score on a scale
Standard Deviation 23.55
|
-1.22 score on a scale
Standard Deviation 18.44
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - EF
|
3.46 score on a scale
Standard Deviation 18.84
|
2.27 score on a scale
Standard Deviation 16.75
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - EF
|
0.60 score on a scale
Standard Deviation 19.86
|
-0.95 score on a scale
Standard Deviation 21.86
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - CF
|
79.51 score on a scale
Standard Deviation 24.24
|
84.54 score on a scale
Standard Deviation 21.14
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - FF
|
0.00 score on a scale
Standard Deviation 22.50
|
-3.37 score on a scale
Standard Deviation 21.05
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - CF
|
1.12 score on a scale
Standard Deviation 21.14
|
-2.08 score on a scale
Standard Deviation 21.11
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - CF
|
0.00 score on a scale
Standard Deviation 24.54
|
-2.65 score on a scale
Standard Deviation 22.30
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - SF
|
70.49 score on a scale
Standard Deviation 25.87
|
80.58 score on a scale
Standard Deviation 22.65
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - SF
|
6.59 score on a scale
Standard Deviation 27.76
|
1.69 score on a scale
Standard Deviation 22.34
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - SF
|
9.74 score on a scale
Standard Deviation 25.23
|
1.70 score on a scale
Standard Deviation 20.69
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - SF
|
9.92 score on a scale
Standard Deviation 25.89
|
0.95 score on a scale
Standard Deviation 21.64
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Fatigue
|
31.83 score on a scale
Standard Deviation 23.56
|
26.92 score on a scale
Standard Deviation 21.92
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Fatigue
|
-0.61 score on a scale
Standard Deviation 24.31
|
-3.62 score on a scale
Standard Deviation 17.55
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Fatigue
|
-7.99 score on a scale
Standard Deviation 21.65
|
-3.66 score on a scale
Standard Deviation 18.66
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Fatigue
|
-4.37 score on a scale
Standard Deviation 23.84
|
-4.42 score on a scale
Standard Deviation 24.09
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Nausea & Vomiting
|
5.38 score on a scale
Standard Deviation 11.47
|
4.64 score on a scale
Standard Deviation 10.96
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Nausea & Vomiting
|
1.83 score on a scale
Standard Deviation 14.79
|
-0.95 score on a scale
Standard Deviation 11.95
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Nausea & Vomiting
|
-1.31 score on a scale
Standard Deviation 10.43
|
-0.57 score on a scale
Standard Deviation 11.43
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Nausea & Vomiting
|
0.99 score on a scale
Standard Deviation 12.77
|
-0.95 score on a scale
Standard Deviation 12.21
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Pain
|
28.82 score on a scale
Standard Deviation 26.10
|
22.51 score on a scale
Standard Deviation 20.84
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Pain
|
-7.14 score on a scale
Standard Deviation 23.46
|
-5.30 score on a scale
Standard Deviation 21.82
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Pain
|
-9.74 score on a scale
Standard Deviation 25.97
|
-6.37 score on a scale
Standard Deviation 20.18
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Pain
|
-8.73 score on a scale
Standard Deviation 27.19
|
-6.06 score on a scale
Standard Deviation 23.59
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Dyspnoea
|
8.68 score on a scale
Standard Deviation 17.60
|
7.56 score on a scale
Standard Deviation 17.68
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Dyspnoea
|
0.73 score on a scale
Standard Deviation 21.65
|
1.89 score on a scale
Standard Deviation 20.44
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Dyspnoea
|
0.75 score on a scale
Standard Deviation 21.89
|
0.00 score on a scale
Standard Deviation 20.84
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Dyspnoea
|
0.40 score on a scale
Standard Deviation 21.64
|
0.38 score on a scale
Standard Deviation 17.86
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Insomnia
|
28.13 score on a scale
Standard Deviation 32.92
|
25.09 score on a scale
Standard Deviation 27.23
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Insomnia
|
4.40 score on a scale
Standard Deviation 31.51
|
-1.12 score on a scale
Standard Deviation 27.27
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Insomnia
|
-3.00 score on a scale
Standard Deviation 34.68
|
0.00 score on a scale
Standard Deviation 27.68
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Insomnia
|
0.00 score on a scale
Standard Deviation 37.67
|
0.76 score on a scale
Standard Deviation 28.58
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Appetite loss
|
11.81 score on a scale
Standard Deviation 21.07
|
10.65 score on a scale
Standard Deviation 18.35
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Appetite loss
|
2.56 score on a scale
Standard Deviation 29.07
|
2.27 score on a scale
Standard Deviation 27.59
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Appetite loss
|
0.00 score on a scale
Standard Deviation 25.62
|
-0.38 score on a scale
Standard Deviation 25.01
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Appetite loss
|
0.00 score on a scale
Standard Deviation 25.87
|
-1.14 score on a scale
Standard Deviation 24.47
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Constipation
|
13.89 score on a scale
Standard Deviation 22.51
|
13.75 score on a scale
Standard Deviation 22.95
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Constipation
|
0.00 score on a scale
Standard Deviation 19.25
|
-2.62 score on a scale
Standard Deviation 21.45
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Constipation
|
0.00 score on a scale
Standard Deviation 25.62
|
-4.92 score on a scale
Standard Deviation 23.99
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Constipation
|
1.98 score on a scale
Standard Deviation 21.55
|
-3.79 score on a scale
Standard Deviation 27.88
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Diarrhoea
|
12.15 score on a scale
Standard Deviation 22.75
|
12.37 score on a scale
Standard Deviation 25.15
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Diarrhoea
|
4.76 score on a scale
Standard Deviation 33.17
|
0.00 score on a scale
Standard Deviation 26.74
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Diarrhoea
|
2.25 score on a scale
Standard Deviation 32.10
|
-0.38 score on a scale
Standard Deviation 24.50
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Diarrhoea
|
4.76 score on a scale
Standard Deviation 32.37
|
1.89 score on a scale
Standard Deviation 29.62
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Baseline - Financial difficulties
|
32.29 score on a scale
Standard Deviation 34.35
|
28.18 score on a scale
Standard Deviation 34.14
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 1 Day 1 - Financial Difficulties
|
-4.40 score on a scale
Standard Deviation 28.20
|
-6.37 score on a scale
Standard Deviation 24.04
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 3 Day 1 - Financial Difficulties
|
-6.37 score on a scale
Standard Deviation 29.68
|
-4.92 score on a scale
Standard Deviation 27.00
|
|
Adjuvant Phase: Change From Baseline in HRQoL Assessed by EORTC QLQ C30 Scores
Change at Cycle 6 Day 1 - Financial Difficulties
|
-6.35 score on a scale
Standard Deviation 30.82
|
-2.65 score on a scale
Standard Deviation 27.32
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ. Number analyzed is the number of HCPs who answered Q1a and Q1c of the HCPQ at the specified timepoint.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: Where was the treatment prepared? Q1c: Which healthcare professionals were involved in the treatment preparation processes? The 4 available response options for Q1a were: Participant's home, Hospital pharmacy, Day oncology unit, or Other. The 5 available response options for Q1c were: Physician, Nurse, Pharmacist, All of them or Other. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=77 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=78 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1c: Pharmacist
|
7.8 percentage of HCPs
|
59.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1c: All of Them
|
2.6 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1c: Other
|
2.6 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1a: Participant's Home
|
0 percentage of HCPs
|
95.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1a: Hospital Pharmacy
|
71.6 percentage of HCPs
|
4.8 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6: Q1a: Day Oncology Unit
|
20.9 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1a: Other
|
7.5 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1c: Physician
|
2.8 percentage of HCPs
|
5.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1c: Nurse
|
29.2 percentage of HCPs
|
88.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1c: Pharmacist
|
58.3 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1c: All of them
|
5.6 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1a: Participant's Home
|
90.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1a: Hospital Pharmacy
|
9.4 percentage of HCPs
|
72.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1a: Day Oncology Unit
|
0 percentage of HCPs
|
17.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1a: Other
|
0 percentage of HCPs
|
9.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1c: Physician
|
11.7 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1c: Nurse
|
75.3 percentage of HCPs
|
35.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1a and 1c of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1c: Other
|
4.2 percentage of HCPs
|
1.3 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1b of the HCPQ. Number analyzed is the number of HCPs who answered Q1b of the HCPQ at the specified timepoint.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the following parts of question Q1b: Q1b(1): How long did it take to prepare the treatment for use? Q1b(2): Time from the preparation place to reach the participant's home.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=19 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=20 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1b(1)
|
5.0 minutes
Interval 1.0 to 30.0
|
5.0 minutes
Interval 1.0 to 33.0
|
|
Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area
Cycle 3 Day 1: Q1b(2)
|
1.0 minutes
Interval 0.0 to 70.0
|
5.0 minutes
Interval 0.0 to 35.0
|
|
Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1b(1)
|
4.0 minutes
Interval 1.0 to 15.0
|
5.0 minutes
Interval 1.0 to 30.0
|
|
Adjuvant Cross-over Period: Duration of Treatment Preparation, According to HCPs' Responses to Question 1b of the HCPQ - Drug Preparation Area
Cycle 6 Day 1: Q1b(2)
|
3.0 minutes
Interval 0.0 to 30.0
|
0.0 minutes
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any of the questions Q2, Q3, and Q4 of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2, and Q3, and Q4 of the HCPQ.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with preparation and/or administration of PH FDC SC completed the questions 2, 3 and 4 of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant´s home, please indicate how strongly you agree or disagree with each of the following statements: 2a: Staff will have increased availability for other tasks in the hospital´s pharmacy. 2b: Administrative procedures related to PH FDC SC will require less time. 2c: Number of preparation steps and staff time commitment are reduced. The 5 response options were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree or Not applicable. Q3: Which took less time? Q4: Which required less use of institutional resources? The 4 available options were: Participant's home, In hospital, No difference, or Unsure. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=75 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=81 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Strongly Disagree
|
1.3 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Disagree
|
18.7 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Neutral
|
16.0 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Agree
|
21.3 percentage of HCPs
|
43.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Strongly Agree
|
37.3 percentage of HCPs
|
38.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2a: Not Applicable
|
5.3 percentage of HCPs
|
9.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Strongly Disagree
|
2.7 percentage of HCPs
|
4.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Disagree
|
24.3 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Neutral
|
13.5 percentage of HCPs
|
13.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Agree
|
18.9 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Strongly Agree
|
35.1 percentage of HCPs
|
35.8 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2b: Not Applicable
|
5.4 percentage of HCPs
|
9.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Strongly Disagree
|
0 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Disagree
|
18.9 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Neutral
|
21.6 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Agree
|
16.2 percentage of HCPs
|
39.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Strongly Agree
|
37.8 percentage of HCPs
|
38.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q2c: Not Applicable
|
5.4 percentage of HCPs
|
11.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q3: Participant's Home
|
22.2 percentage of HCPs
|
59.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q3: In hospital
|
36.1 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q3: No Difference
|
31.9 percentage of HCPs
|
11.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q3: Unsure
|
9.7 percentage of HCPs
|
26.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q4: Participant's Home
|
38.9 percentage of HCPs
|
73.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q4: In hospital
|
36.1 percentage of HCPs
|
5.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q4: No Difference
|
19.4 percentage of HCPs
|
8.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 2, 3 and 4 of the HCPQ - Drug Preparation Area
Q4: Unsure
|
5.6 percentage of HCPs
|
12.7 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ. Number analyzed is the number of HCPs who answered Q1a to Q1f of the HCPQ at the specified timepoint.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1a: How long did it take to travel to the participant's home to administer PH FDC SC? Q1b: How long did it take for the participant to travel to the hospital to receive PH FDC SC? Q1c: How long did it take to administer PH FDC SC? Q1d: How long was the participant treatment time? Q1e: How much time did the participant spend in hospital? Q1f: How much time did you spend at the participant's home? From arrival to departure time.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=76 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=81 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1b
|
60.0 minutes
Interval 10.0 to 660.0
|
60.0 minutes
Interval 10.0 to 420.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1c
|
5.0 minutes
Interval 5.0 to 30.0
|
5.0 minutes
Interval 5.0 to 13.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1d
|
75.0 minutes
Interval 5.0 to 240.0
|
30.0 minutes
Interval 5.0 to 540.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1e
|
180.0 minutes
Interval 70.0 to 360.0
|
120.0 minutes
Interval 25.0 to 586.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1a
|
60.0 minutes
Interval 11.0 to 540.0
|
82.5 minutes
Interval 60.0 to 105.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1f
|
90.0 minutes
Interval 40.0 to 175.0
|
—
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1a
|
85.0 minutes
Interval 50.0 to 180.0
|
65.0 minutes
Interval 5.0 to 480.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1b
|
60.0 minutes
Interval 5.0 to 660.0
|
60.0 minutes
Interval 15.0 to 480.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1c
|
5.0 minutes
Interval 5.0 to 10.0
|
5.0 minutes
Interval 5.0 to 30.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1d
|
30.0 minutes
Interval 5.0 to 240.0
|
90.0 minutes
Interval 8.0 to 165.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1e
|
120.0 minutes
Interval 25.0 to 480.0
|
120.0 minutes
Interval 50.0 to 600.0
|
|
Adjuvant Cross-over Period: Duration of Administering Treatment, According to HCPs' Responses to Question 1a to 1f of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1f
|
90.0 minutes
Interval 90.0 to 90.0
|
90.0 minutes
Interval 20.0 to 165.0
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 3 and 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ. Number analyzed is the number of HCPs who answered Q1g to Q1i of the HCPQ at the specified timepoint.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1g. Does the participant still have implanted IV access? The 2 available responses were: Yes or No. Q1h: If question 1g was answered 'No', when was the IV access removed? The 3 available responses were: After surgery and before initiating adjuvant treatment; After initiating adjuvant treatment, or Not applicable. Q1i: If question 1g was answered 'Yes', what is the main reason to keep the IV access? The 5 available responses were: Local protocol; Risk of recurrence; Participant preference; Not applicable, or Other. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=61 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=59 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1g: Yes
|
14.5 percentage of HCPs
|
35.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1g: No
|
85.5 percentage of HCPs
|
64.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1h: After Surgery and Before Adjuvant Treatment
|
4.3 percentage of HCPs
|
7.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1h: After Initiating Adjuvant Treatment
|
10.6 percentage of HCPs
|
7.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1h: Not Applicable
|
85.1 percentage of HCPs
|
85.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1i: Local Protocol
|
21.4 percentage of HCPs
|
45.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1i: Risk of Recurrence
|
14.3 percentage of HCPs
|
10.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1i: Participant Preference
|
14.3 percentage of HCPs
|
25.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1i: Not Applicable
|
50.0 percentage of HCPs
|
15.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 3 Day 1: Q1i: Other
|
0 percentage of HCPs
|
5.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1g: Yes
|
23.0 percentage of HCPs
|
23.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1g: No
|
77.0 percentage of HCPs
|
76.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1h: After Surgery and Before Adjuvant Treatment
|
6.4 percentage of HCPs
|
10.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1h: After Initiating Adjuvant Treatment
|
6.4 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1h: Not Applicable
|
87.2 percentage of HCPs
|
89.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1i: Local Protocol
|
42.9 percentage of HCPs
|
27.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1i: Risk of Recurrence
|
4.8 percentage of HCPs
|
3.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1i: Participant Preference
|
4.8 percentage of HCPs
|
13.8 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1i: Not Applicable
|
38.1 percentage of HCPs
|
51.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1g, 1h, and 1i of the HCPQ - Administering Treatment
Cycle 6 Day 1: Q1i: Other
|
9.5 percentage of HCPs
|
3.4 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q1j to Q1l of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q1j to Q1l) of the HCPQ.
HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q1j: How long do you keep implanted IV access in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer participants with pCR following surgery in your institution? The 5 available responses were: \<12 months, ≥12 months, 18 months, \<24 months, ≥24 months. Q1k: When is the decision point for you to decide to remove IV access for early HER2+ breast cancer participants? The 6 available responses were: Before surgery, After surgery, After PCR results, After completion of full adjuvant therapy, After completion of IV antineoplastic within adjuvant therapy, and Other. Q1l: Do you consider it necessary to keep implanted IV access knowing that the participant's treatment will be SC until the full 18 cycles? The 3 available responses were: Yes, No, and Unsure. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=43 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=44 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1j: <12 Months
|
27.0 percentage of HCPs
|
10.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1j: ≥12 Months
|
16.2 percentage of HCPs
|
28.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1j: 18 Months
|
16.2 percentage of HCPs
|
14.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1j: <24 Months
|
8.1 percentage of HCPs
|
3.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1j: ≥24 Months
|
32.4 percentage of HCPs
|
42.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: Before Surgery
|
2.6 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: After Surgery
|
10.3 percentage of HCPs
|
2.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: After PCR Results
|
20.5 percentage of HCPs
|
15.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: After Completion of Full Adjuvant Therapy
|
28.2 percentage of HCPs
|
15.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: After Completion of IV Antineoplastic Within Adjuvant Therapy
|
5.1 percentage of HCPs
|
29.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1k: Other
|
33.3 percentage of HCPs
|
36.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1l: Yes
|
37.2 percentage of HCPs
|
11.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1l: No
|
37.2 percentage of HCPs
|
35.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 1j, 1k, and 1l of the HCPQ - Administering Treatment
Q1l: Unsure
|
25.6 percentage of HCPs
|
52.4 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered Q2 of the HCPQ. Number analyzed is the number of HCPs who answered each sub-question of Q2 (Q2a-Q2h) of the HCPQ. Percentages were rounded off.
HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following question of the HCPQ: Q2: If all PH FDC SC injections were switched from an in-hospital setting to the participant's home, please indicate how strongly you agree/disagree with each of the following statements: 2a: PH FDC SC's SC route of administration allows for more flexible treatment scheduling. 2b: Frees up infusion chairs or outpatient procedure rooms used to administer SC injections. 2c: Waiting list for infusion chairs or outpatient procedure rooms is reduced. 2d: Staff's work burden is reduced, enhancing work performance. 2e: More interaction time between HCPs and participants on IV treatment. 2f: Staff has more time for administrative tasks. 2g: Participants will spend less time in hospital. 2h: Participants prefer PH FDC SC at home. The 6 available responses were: Strongly disagree, Disagree, Neutral, Agree, Strongly agree, \& Not applicable.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=75 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=79 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Agree
|
33.3 percentage of HCPs
|
26.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Strongly Agree
|
33.3 percentage of HCPs
|
43.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Not Applicable
|
10.7 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Strongly Disagree
|
0 percentage of HCPs
|
7.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Disagree
|
4.0 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Neutral
|
25.3 percentage of HCPs
|
9.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Agree
|
22.7 percentage of HCPs
|
32.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Strongly Agree
|
40.0 percentage of HCPs
|
47.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2f: Not Applicable
|
8.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Strongly Disagree
|
0 percentage of HCPs
|
6.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Disagree
|
1.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Neutral
|
6.7 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Agree
|
32.0 percentage of HCPs
|
24.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Strongly Agree
|
56.0 percentage of HCPs
|
67.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2g: Not Applicable
|
4.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Strongly Disagree
|
2.7 percentage of HCPs
|
6.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Disagree
|
18.7 percentage of HCPs
|
3.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Neutral
|
28.0 percentage of HCPs
|
15.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Agree
|
17.3 percentage of HCPs
|
23.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Strongly Agree
|
29.3 percentage of HCPs
|
49.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2h: Not Applicable
|
4.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Strongly Disagree
|
0 percentage of HCPs
|
6.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Disagree
|
1.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Neutral
|
8.0 percentage of HCPs
|
6.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Agree
|
41.3 percentage of HCPs
|
30.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Strongly Agree
|
45.3 percentage of HCPs
|
55.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2a: Not Applicable
|
4.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Strongly Disagree
|
1.3 percentage of HCPs
|
6.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Disagree
|
5.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Neutral
|
6.7 percentage of HCPs
|
7.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Agree
|
33.3 percentage of HCPs
|
29.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Strongly Agree
|
49.3 percentage of HCPs
|
55.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2b: Not Applicable
|
4.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Strongly Disagree
|
2.7 percentage of HCPs
|
7.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Disagree
|
1.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Neutral
|
5.3 percentage of HCPs
|
0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Agree
|
33.3 percentage of HCPs
|
33.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Strongly Agree
|
53.3 percentage of HCPs
|
57.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2c: Not Applicable
|
4.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Strongly Disagree
|
0 percentage of HCPs
|
6.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Disagree
|
9.3 percentage of HCPs
|
3.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Neutral
|
14.7 percentage of HCPs
|
14.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Agree
|
25.3 percentage of HCPs
|
27.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Strongly Agree
|
42.7 percentage of HCPs
|
46.8 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2d: Not Applicable
|
8.0 percentage of HCPs
|
1.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Strongly Disagree
|
0 percentage of HCPs
|
6.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Disagree
|
2.7 percentage of HCPs
|
2.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Question 2 of the HCPQ - Administering Treatment
Q2e: Neutral
|
20.0 percentage of HCPs
|
19.2 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 6 (Cycle length = 21 days)Population: Overall number analyzed is the number of HCPs who answered any of the questions from Q3 to Q7 of the HCPQ. Number analyzed is the number of HCPs who answered each specific question (Q3 to Q7) of the HCPQ.
HCP was defined as any personnel involved in the drug preparation and/or drug administration processes. HCPs who have had experience with the preparation and/or administration of PH FDC SC completed the following questions of the HCPQ: Q3: Which was more convenient for the participant? Q4: Which was better for optimising participant care? Q5: Which required less use of institutional resources? Q6: Which was preferred by participants? The 4 responses available were: Participant's home, In hospital, No difference, and Unsure. Q7: How frequently would you recommend PH FDC SC at home to your participants in the future? The 3 responses available were: Always, Sometimes, and Never. Percentages were rounded off.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=74 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=81 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q3: Participant's Home
|
45.9 percentage of HCPs
|
84.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q3: In Hospital
|
40.5 percentage of HCPs
|
7.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q3: No Difference
|
6.8 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q3: Unsure
|
6.8 percentage of HCPs
|
2.5 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q4: Participant's Home
|
28.4 percentage of HCPs
|
80.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q4: In Hospital
|
52.7 percentage of HCPs
|
7.4 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q4: No Difference
|
12.2 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q4: Unsure
|
6.8 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q5: Participant's Home
|
40.5 percentage of HCPs
|
67.9 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q5: In Hospital
|
27.0 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q5: No Difference
|
16.2 percentage of HCPs
|
17.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q5: Unsure
|
16.2 percentage of HCPs
|
8.6 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q6: Participant's Home
|
41.9 percentage of HCPs
|
79.0 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q6: In Hospital
|
44.6 percentage of HCPs
|
11.1 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q6: No Difference
|
6.8 percentage of HCPs
|
6.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q6: Unsure
|
6.8 percentage of HCPs
|
3.7 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q7: Always
|
43.8 percentage of HCPs
|
80.2 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q7: Sometimes
|
43.8 percentage of HCPs
|
17.3 percentage of HCPs
|
|
Adjuvant Cross-over Period: Percentage of HCPs by Their Responses to Questions 3 to 7 of the HCPQ - Administering Treatment
Q7: Never
|
12.3 percentage of HCPs
|
2.5 percentage of HCPs
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 1 and 6 (1 Cycle = 21 days)EORTC QLQ-C30=cancer-specific instrument consisting of 30 questions that evaluated 5 aspects of participant functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting \& pain), GHS/QoL \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties). Functioning \& symptom items used a 4-point scale, scores ranging from 1=Not at all to 4=Very much. GHS/QoL questions used a 7-point scale, scores ranging from 1=Very poor to 7=Excellent. All EORTC scales \& single-item measures were linearly transformed to a score range of 0-100. High score for functional/GHS scale=high/healthy level of functioning/better HRQoL \& high score for symptom scale=high level of symptom severity. A positive change from baseline=improvement \& negative change=worsening in QoL \& functioning scales. A positive change from baseline=deterioration \& negative change=improvement in symptom scales.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Upon completion of adjuvant cross-over period (Day 1 of Cycle 8 or 9; Cycle length = 21 days)Population: The analysis includes all randomized participants assigned into the cross-over period who received at least one dose of PH FDC SC and entered the treatment continuation phase.
The percentage of participants who chose to receive PH FDC SC in the home setting or in the hospital setting during the treatment continuation period is reported.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=92 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=96 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period
Choice of Home Setting
|
54.3 Percentage of participants
|
68.8 Percentage of participants
|
|
Percentage of Participants Who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period
Choice of Hospital Setting
|
45.7 Percentage of participants
|
31.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 7.4 months)Population: Neoadjuvant safety analysis set (SASab) included all randomized participants who received at least one study treatment during the neoadjuvant phase.
AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in left ventricular ejection fraction (LVEF) of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; congestive heart failure (CHF). AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=228 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=115 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs
AEs
|
227 Participants
|
113 Participants
|
|
Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs
SAEs
|
43 Participants
|
19 Participants
|
|
Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs
Grade ≥ 3 AEs
|
103 Participants
|
46 Participants
|
|
Neoadjuvant Phase: Number of Participants With Adverse Events (AEs), Grade ≥ 3 AEs, Serious AEs (SAEs), and Cardiac AEs
Cardiac AEs
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Cycle 8 (1 Cycle = 21 days)Population: SASab included all randomized participants who received at least one study treatment during the neoadjuvant phase.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=228 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=115 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Neoadjuvant Phase: Number of Participants With Premature Withdrawal From PH FDC SC and P+H IV Due to AEs
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 5.8 months)Population: Adjuvant safety analysis set (SAScd+) included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase. AEs for the cross-over period are pooled per treatment administration setting.
AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=191 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=190 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
AEs
|
89 Participants
|
99 Participants
|
|
Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
SAEs
|
1 Participants
|
1 Participants
|
|
Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
Cardiac AEs
|
2 Participants
|
1 Participants
|
|
Adjuvant Cross-over Period: Number of Participants With AEs, Grade ≥ 3 AEs, SAEs, and Cardiac AEs
Grade ≥3 AEs
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Cycle 6 (Cycle length = 21 days)Population: SAScd+ included all participants with pCR who received at least one dose of PH FDC SC during the adjuvant phase. AEs for the cross-over period are pooled per treatment administration setting.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinued the study due to AEs are reported here.
Outcome measures
| Measure |
Arm B, Neoadjuvant Phase: PH FDC SC
n=191 Participants
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm A, Neoadjuvant Phase: P+H IV
n=190 Participants
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
|---|---|---|
|
Adjuvant Cross-over Period: Number of Participants With Premature Withdrawal From PH FDC SC Due to AEs
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From initiation of study treatment until 28 days after the last treatment cycle (up to approximately 3.5 years)AE was defined as any untoward medical occurrence in a clinical study participant temporally associated with use of a study treatment, whether or not considered related to the study treatment. SAE=any untoward medical occurrence that, at any dose: Results in death; Is life threatening; Requires inpatient hospitalization/prolongation of existing hospitalization; Results in persistent disability/incapacity \&/or is a congenital anomaly/birth defect. Cardiac AEs=asymptomatic decline in LVEF of ≥10% from baseline to an LVEF \<50%; asymptomatic decline in LVEF requiring treatment/leading to discontinuation of study treatment; CHF. AEs ≥Grade 3=marked limitation of physical activity. Comfortable at rest, but any ordinary activity causes fatigue, palpitation/dyspnea; Inability to carry any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. Any physical activity leads to discomfort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of study treatment in the adjuvant phase until 28 days after the last treatment cycle (up to approximately 3.5 years)An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study intervention. Participants who discontinue study due to AEs will be reported.
Outcome measures
Outcome data not reported
Adverse Events
Arm A, Neoadjuvant Phase: P+H IV
Serious events: 19 serious events
Other events: 113 other events
Deaths: 0 deaths
Arm B, Neoadjuvant Phase: PH FDC SC
Serious events: 43 serious events
Other events: 222 other events
Deaths: 4 deaths
Adjuvant Run-in Phase: PH FDC SC in Hospital
Serious events: 3 serious events
Other events: 84 other events
Deaths: 0 deaths
Adjuvant Cross-Over Phase: PH FDC SC in Hospital
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
Adjuvant Cross-Over Phase: PH FDC SC at Home
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Adjuvant Continuation Phase: PH FDC SC in Hospital
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Adjuvant Continuation Phase: PH FDC SC at Home
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Arm E, Adjuvant Phase: Trastuzumab Emtansine IV
Serious events: 9 serious events
Other events: 107 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A, Neoadjuvant Phase: P+H IV
n=115 participants at risk
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm B, Neoadjuvant Phase: PH FDC SC
n=228 participants at risk
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Adjuvant Run-in Phase: PH FDC SC in Hospital
n=194 participants at risk
Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).
|
Adjuvant Cross-Over Phase: PH FDC SC in Hospital
n=190 participants at risk
Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the hospital setting during the cross-over period (Cycle length = 21 days).
|
Adjuvant Cross-Over Phase: PH FDC SC at Home
n=191 participants at risk
Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the home setting during the cross-over period (Cycle length = 21 days).
|
Adjuvant Continuation Phase: PH FDC SC in Hospital
n=84 participants at risk
Participants who completed the cross-over period and opted to receive further treatment in the hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Adjuvant Continuation Phase: PH FDC SC at Home
n=114 participants at risk
Participants who completed the cross-over period and opted to receive further treatment at home received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm E, Adjuvant Phase: Trastuzumab Emtansine IV
n=117 participants at risk
Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 90 minutes as an initial dose. Thereafter, participants received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.87%
1/115 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
4/228 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Atypical haemolytic uraemic syndrome
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.1%
7/228 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
2/115 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
4/228 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.3%
3/228 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.1%
7/228 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.3%
3/228 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
2/228 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Asthenia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Pyrexia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Abscess limb
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Cellulitis
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Clostridium difficile infection
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Enteritis infectious
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Gastroenteritis
|
0.87%
1/115 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Infected seroma
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Infection
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Malaria
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Mastitis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Pneumonia
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
2/115 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Sepsis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Urinary tract infection
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Wound infection
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
2/228 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Coma scale abnormal
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Neutrophil count decreased
|
1.7%
2/115 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.3%
3/228 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Platelet count decreased
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
2/228 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Seizure
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Syncope
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/115 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.44%
1/228 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Vascular disorders
Hypotension
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
2/228 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Vascular disorders
Hypovolaemic shock
|
0.87%
1/115 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Product Issues
Device breakage
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/228 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
Other adverse events
| Measure |
Arm A, Neoadjuvant Phase: P+H IV
n=115 participants at risk
Participants received a loading dose of pertuzumab, 840 milligrams (mg), and trastuzumab, 8 milligrams per kilogram (mg/kg), as an IV infusion on Day 1 of Cycle 1 (Cycle length = 21 days), followed by maintenance doses of pertuzumab, 420 mg and trastuzumab, 6 mg/kg, as an IV infusion, every 3 weeks (Q3W) along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Arm B, Neoadjuvant Phase: PH FDC SC
n=228 participants at risk
Participants received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and recombinant human PH20 hyaluronidase (rHuPH20), 30,000 units (U), as a SC injection on Day 1 of Cycle 1 (Cycle length = 21 days) followed by maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, Q3W along with neoadjuvant chemotherapy based on investigator's choice, for 6-8 cycles (depending on the chosen neoadjuvant scheme).
|
Adjuvant Run-in Phase: PH FDC SC in Hospital
n=194 participants at risk
Participants who achieved pathologic complete response (pCR) after surgery received a loading dose of pertuzumab, 1200 mg, trastuzumab, 600 mg, and rHuPH20, 30,000 U, as a SC injection on Day 1 of Cycle 1 followed by maintenance dose of pertuzumab, 600 mg, trastuzumab, 600 mg and rHuPH20, 20,000 U, as a SC injection, on Day 1 of Cycle 2 (Cycle length = 21 days).
|
Adjuvant Cross-Over Phase: PH FDC SC in Hospital
n=190 participants at risk
Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the hospital setting during the cross-over period (Cycle length = 21 days).
|
Adjuvant Cross-Over Phase: PH FDC SC at Home
n=191 participants at risk
Participants who completed the run-in period received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection for 3 cycles in the home setting during the cross-over period (Cycle length = 21 days).
|
Adjuvant Continuation Phase: PH FDC SC in Hospital
n=84 participants at risk
Participants who completed the cross-over period and opted to receive further treatment in the hospital setting received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Adjuvant Continuation Phase: PH FDC SC at Home
n=114 participants at risk
Participants who completed the cross-over period and opted to receive further treatment at home received maintenance doses of pertuzumab, 600 mg, trastuzumab, 600 mg, and rHuPH20, 20,000 U, as a SC injection up to a maximum of 18 cycles (Cycle length = 21 days).
|
Arm E, Adjuvant Phase: Trastuzumab Emtansine IV
n=117 participants at risk
Participants who did not achieve pCR after surgery received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 90 minutes as an initial dose. Thereafter, participants received trastuzumab emtansine, 3.6 mg/kg, as an IV infusion for 30 minutes, Q3W for 14 cycles (Cycle length = 21 days).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
53.0%
61/115 • Number of events 82 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
42.1%
96/228 • Number of events 128 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/190 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
2/114 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
17.1%
20/117 • Number of events 29 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.3%
13/115 • Number of events 29 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
11.4%
26/228 • Number of events 47 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/191 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
11.1%
13/117 • Number of events 26 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.0%
8/115 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
12/228 • Number of events 18 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.8%
8/117 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.1%
22/115 • Number of events 36 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
26.3%
60/228 • Number of events 97 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/191 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
18.8%
22/117 • Number of events 52 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.4%
12/115 • Number of events 22 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
9.2%
21/228 • Number of events 33 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
21.4%
25/117 • Number of events 42 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Eye disorders
Dry eye
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.6%
15/228 • Number of events 20 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
5/115 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.9%
18/228 • Number of events 21 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
9/115 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.0%
16/228 • Number of events 20 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.4%
2/84 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.4%
4/117 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Constipation
|
12.2%
14/115 • Number of events 14 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.7%
29/228 • Number of events 45 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/190 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/191 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.0%
14/117 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
62.6%
72/115 • Number of events 145 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
64.5%
147/228 • Number of events 274 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.2%
12/194 • Number of events 14 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.7%
9/190 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.7%
7/191 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
6/114 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.0%
7/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
14/115 • Number of events 20 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.3%
28/228 • Number of events 32 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
7/115 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.1%
14/228 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.4%
2/84 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Nausea
|
55.7%
64/115 • Number of events 94 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
59.6%
136/228 • Number of events 245 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/194 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/114 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
15.4%
18/117 • Number of events 26 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Stomatitis
|
11.3%
13/115 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
13.6%
31/228 • Number of events 37 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.3%
5/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
25/115 • Number of events 34 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
25.0%
57/228 • Number of events 81 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
2/114 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Asthenia
|
15.7%
18/115 • Number of events 30 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
15.8%
36/228 • Number of events 54 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.5%
3/194 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/190 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/191 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.5%
10/117 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Fatigue
|
35.7%
41/115 • Number of events 59 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
37.7%
86/228 • Number of events 131 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.6%
9/194 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.2%
6/190 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
14.5%
17/117 • Number of events 18 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Influenza like illness
|
2.6%
3/115 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
12/228 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.4%
4/117 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Mucosal inflammation
|
16.5%
19/115 • Number of events 26 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
15.4%
35/228 • Number of events 46 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Oedema peripheral
|
7.8%
9/115 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.6%
15/228 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Pain
|
6.1%
7/115 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.8%
11/228 • Number of events 13 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
General disorders
Pyrexia
|
5.2%
6/115 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
11.8%
27/228 • Number of events 31 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/194 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/191 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
COVID-19
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.4%
10/228 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.0%
7/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
3/115 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.6%
15/228 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/191 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.8%
8/117 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Infections and infestations
Urinary tract infection
|
11.3%
13/115 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
11.4%
26/228 • Number of events 31 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/191 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.7%
9/117 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.2%
14/115 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
12/228 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.0%
8/115 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.2%
5/228 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.5%
3/194 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/115 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.3%
3/228 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
13.9%
27/194 • Number of events 27 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/190 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
22.2%
26/117 • Number of events 26 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Alanine aminotransferase increased
|
10.4%
12/115 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
11.4%
26/228 • Number of events 36 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.5%
3/194 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
16.2%
19/117 • Number of events 24 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Aspartate aminotransferase increased
|
9.6%
11/115 • Number of events 14 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.8%
20/228 • Number of events 27 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
22.2%
26/117 • Number of events 34 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.3%
5/115 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
6/228 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.5%
10/117 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.1%
7/115 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.5%
8/228 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.8%
8/117 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Neutrophil count decreased
|
7.0%
8/115 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
13.2%
30/228 • Number of events 67 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.3%
5/117 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Platelet count decreased
|
4.3%
5/115 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.4%
10/228 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
10.3%
12/117 • Number of events 14 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
Weight decreased
|
8.7%
10/115 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.5%
17/228 • Number of events 17 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Investigations
White blood cell count decreased
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
12/228 • Number of events 21 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/194 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
15/115 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
19.7%
45/228 • Number of events 56 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.7%
9/117 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
8/115 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.3%
3/228 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.3%
13/115 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
10.1%
23/228 • Number of events 25 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.7%
11/194 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/190 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.2%
8/191 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.4%
5/114 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
26.5%
31/117 • Number of events 41 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
9/115 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.5%
17/228 • Number of events 18 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.3%
13/115 • Number of events 19 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.3%
28/228 • Number of events 35 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/114 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.7%
9/117 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
5/115 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.4%
10/228 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/191 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Dizziness
|
7.0%
8/115 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.8%
11/228 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/114 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.1%
6/117 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Dysgeusia
|
11.3%
13/115 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
14.5%
33/228 • Number of events 36 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Headache
|
13.9%
16/115 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
16.2%
37/228 • Number of events 44 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.6%
9/194 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/191 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
6/114 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
10.3%
12/117 • Number of events 13 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Neuropathy peripheral
|
13.9%
16/115 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
18.0%
41/228 • Number of events 45 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/194 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.0%
14/117 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Paraesthesia
|
4.3%
5/115 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
9.2%
21/228 • Number of events 25 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.0%
7/117 • Number of events 9 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.8%
9/115 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.8%
20/228 • Number of events 20 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
14.5%
17/117 • Number of events 20 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Psychiatric disorders
Anxiety
|
7.0%
8/115 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.1%
7/228 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.3%
5/117 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Psychiatric disorders
Insomnia
|
9.6%
11/115 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.6%
15/228 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/194 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.5%
10/117 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Renal and urinary disorders
Dysuria
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
12/228 • Number of events 13 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
12/115 • Number of events 12 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
9.2%
21/228 • Number of events 22 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/194 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.1%
2/190 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/191 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.3%
6/114 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.7%
9/117 • Number of events 11 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
6/115 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.9%
9/228 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.4%
4/117 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
10/115 • Number of events 14 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
9.6%
22/228 • Number of events 31 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
12.0%
14/117 • Number of events 18 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
49.6%
57/115 • Number of events 60 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
54.4%
124/228 • Number of events 131 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.5%
3/194 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.53%
1/190 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
5/115 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
7.5%
17/228 • Number of events 18 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.6%
3/190 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
5.2%
6/115 • Number of events 6 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.2%
5/228 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.85%
1/117 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.5%
4/115 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
5.7%
13/228 • Number of events 13 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.7%
2/117 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
10/115 • Number of events 10 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.6%
15/228 • Number of events 16 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/194 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/190 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.7%
7/191 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
3.6%
3/84 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
4.3%
5/117 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
11/115 • Number of events 13 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
8.8%
20/228 • Number of events 21 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/194 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.1%
4/190 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/191 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.2%
1/84 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.88%
1/114 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.8%
8/117 • Number of events 8 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Vascular disorders
Flushing
|
5.2%
6/115 • Number of events 7 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
4/228 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/194 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/190 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/191 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/114 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/117 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
|
Vascular disorders
Hot flush
|
3.5%
4/115 • Number of events 4 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
6.1%
14/228 • Number of events 15 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.52%
1/194 • Number of events 1 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
5/190 • Number of events 5 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.0%
2/191 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
0.00%
0/84 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
1.8%
2/114 • Number of events 2 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
2.6%
3/117 • Number of events 3 • From initiation of study treatment until 28 days after the last treatment cycle (Neoadjuvant phase: up to 7.4 months; Adjuvant phase: up to 12.3 months)
SASab=all randomized participants who received at least 1 study treatment during NP. SAScd+=all participants with pCR who received ≥1 dose of PH FDC SC in AP. AEs for cross-over period are pooled per treatment administration setting; some participants discontinued after receiving treatment in 1 setting but not the other. Participants that switched between administration settings during continuation period are counted in both settings. Final AE data will be reported 1 year after study completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER