Safety Summary of the FDC SC and IV Formulations: Number of Participants With at Least One Adverse Event During the Treatment Cross-Over and Treatment Continuation Periods
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 of Cycle 1 to end of Cycle 6 of the Treatment Cross-Over Period; from Day 1 of Cycle 7 up to the completion of 18 cycles of neo/adjuvant anti-HER2 treatment in the Treatment Continuation Period (1 cycle is 21 days)
What was measured
Investigators used the NCI CTCAE v4.0 grading scale for assessing adverse event (AE) severity; if not listed, AE severity was graded as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE. Severity and seriousness are not synonymous and investigators independently assessed these criteria for each AE. Investigators also determined whether an AE was considered to be related to the study drug. Adverse events to monitor were defined based on known risks associated with the study drugs and included: hypersensitivity reactions, administration-related reactions (ARRs), cardiac dysfunction, diarrhea grade ≥3, rash/skin reactions, mucositis, interstitial lung disease (ILD), (febrile) neutropenia, pulmonary events that may occur as a result of an ARR, and pregnancy/neonatal related. Multiple occurrences of AEs were counted only once per participant. LVEF = left ventricular ejection fraction
Analysis population: Safety Population: All participants who received at least one dose of any study treatment categorized according to the study treatment administered. In this analysis, participants are grouped by treatment received during the Cross-Over and Continuation Periods.
Groups in this outcome
P+H IV: Treatment Cross-Over Period
This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.
PH FDC SC: Treatment Cross-Over Period
This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Cross-Over Period of the study.
P+H IV: Treatment Continuation Period
This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
PH FDC SC: Treatment Continuation Period
This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
P+H IV: Treatment Cross-Over Period
160
PH FDC SC: Treatment Cross-Over Period
160
P+H IV: Treatment Continuation Period
21
PH FDC SC: Treatment Continuation Period
138
Reported measurements
Any Adverse Event (AE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
113
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
122
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
14
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
92
Not reported
Not reported
Not reported
Not reported
AE with Fatal Outcome
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Related AE with Fatal Outcome
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Grade 3 to 5 AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
5
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
4
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
2
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
7
Not reported
Not reported
Not reported
Not reported
Related Grade 3 to 5 AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Cardiac AE (Including LVEF Events)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
3
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
5
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
Serious AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
6
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
2
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
4
Not reported
Not reported
Not reported
Not reported
Anaphylaxis and Hypersensitivity AE, All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
3
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
2
Not reported
Not reported
Not reported
Not reported
Anaphylaxis and Hypersensitivity AE, Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Administration Related Reaction AE, All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
9
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
38
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
16
Not reported
Not reported
Not reported
Not reported
Administration Related Reaction AE, Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Cardiac Dysfunction AE, All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
5
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
4
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
2
Not reported
Not reported
Not reported
Not reported
Cardiac Dysfunction AE, Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Diarrhea Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Rash/Skin Reactions
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Mucositis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Pulmonary Events (ARR), All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
26
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
12
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
5
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
13
Not reported
Not reported
Not reported
Not reported
Pulmonary Events (ARR), Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Pregnancy and Neonatal Related AEs, All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Pregnancy and Neonatal Related AEs, Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Interstitial Lung Disease (ILD), All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
Interstitial Lung Disease (ILD), Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Neutropenia/Febrile Neutropenia, All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
7
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
3
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
5
Not reported
Not reported
Not reported
Not reported
Neutropenia/Febrile Neutropenia, Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
Local Infusion Site Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Systemic Infusion Site Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
6
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
Local Injection Site Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
36
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
13
Not reported
Not reported
Not reported
Not reported
Systemic Injection Site Reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
3
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
2
Not reported
Not reported
Not reported
Not reported
AE Leading to Any Study Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
AE Leading to PH FDC SC Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
1
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
AE Leading to Pertuzumab IV Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
AE Leading to Trastuzumab IV Discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
0
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
0
Not reported
Not reported
Not reported
Not reported
AE Leading to Any Study Treatment Interruption or Dose Reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
P+H IV: Treatment Cross-Over Period
4
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Cross-Over Period
2
Not reported
Not reported
Not reported
Not reported
P+H IV: Treatment Continuation Period
1
Not reported
Not reported
Not reported
Not reported
PH FDC SC: Treatment Continuation Period
8
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
113
group Id
OG001
value
122
group Id
OG002
value
14
group Id
OG003
value
92
title
Any Adverse Event (AE)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
AE with Fatal Outcome
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Related AE with Fatal Outcome
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
group Id
OG002
value
2
group Id
OG003
value
7
title
Grade 3 to 5 AE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Related Grade 3 to 5 AE
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
1
group Id
OG003
value
1
title
Cardiac AE (Including LVEF Events)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
4
title
Serious AE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
2
title
Anaphylaxis and Hypersensitivity AE, All Grades
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Anaphylaxis and Hypersensitivity AE, Grade ≥3
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
38
group Id
OG002
value
1
group Id
OG003
value
16
title
Administration Related Reaction AE, All Grades
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Administration Related Reaction AE, Grade ≥3
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
group Id
OG002
value
1
group Id
OG003
value
2
title
Cardiac Dysfunction AE, All Grades
denoms
counts
group Id
OG000
value
160
group Id
OG001
value
160
group Id
OG002
value
21
group Id
OG003
value
138
units
Participants
description
Investigators used the NCI CTCAE v4.0 grading scale for assessing adverse event (AE) severity; if not listed, AE severity was graded as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE. Severity and seriousness are not synonymous and investigators independently assessed these criteria for each AE. Investigators also determined whether an AE was considered to be related to the study drug. Adverse events to monitor were defined based on known risks associated with the study drugs and included: hypersensitivity reactions, administration-related reactions (ARRs), cardiac dysfunction, diarrhea grade ≥3, rash/skin reactions, mucositis, interstitial lung disease (ILD), (febrile) neutropenia, pulmonary events that may occur as a result of an ARR, and pregnancy/neonatal related. Multiple occurrences of AEs were counted only once per participant. LVEF = left ventricular ejection fraction
groups
description
This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.
id
OG000
title
P+H IV: Treatment Cross-Over Period
description
This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Cross-Over Period of the study.
id
OG001
title
PH FDC SC: Treatment Cross-Over Period
description
This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
id
OG002
title
P+H IV: Treatment Continuation Period
description
This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
id
OG003
title
PH FDC SC: Treatment Continuation Period
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: All participants who received at least one dose of any study treatment categorized according to the study treatment administered. In this analysis, participants are grouped by treatment received during the Cross-Over and Continuation Periods.
reporting Status
POSTED
time Frame
From Day 1 of Cycle 1 to end of Cycle 6 of the Treatment Cross-Over Period; from Day 1 of Cycle 7 up to the completion of 18 cycles of neo/adjuvant anti-HER2 treatment in the Treatment Continuation Period (1 cycle is 21 days)
title
Safety Summary of the FDC SC and IV Formulations: Number of Participants With at Least One Adverse Event During the Treatment Cross-Over and Treatment Continuation Periods
Triangle