Safety Summary for Assessment of Switching Between the FDC SC and IV Formulations: Number of Participants With at Least One Adverse Event During the Treatment Cross-Over Period by Study Arm and Treatment Received
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 the end of Cycle 3 of Cross-Over Period; from Day 1 of Cycle 4 to the end of Cycle 6 of Cross-Over 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 study arm and treatment received during the Cross-Over Period.
Groups in this outcome
Arm A: Treatment With P+H IV (Cycles 1 to 3)
This safety analysis population only includes the adverse events that occurred in Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
This safety analysis population only includes adverse events that occurred in Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
Arm B: Treatment With P+H IV (Cycles 4 to 6)
This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
80
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
80
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
80
Arm B: Treatment With P+H IV (Cycles 4 to 6)
80
Reported measurements
Any Adverse Event (AE)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
62
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
60
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
62
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
51
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
3
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
4
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
2
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
3
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
2
Not reported
Not reported
Not reported
Not reported
Serious AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
5
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
2
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Administration Related Reaction (ARR), All Grades
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
7
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
14
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
24
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
2
Not reported
Not reported
Not reported
Not reported
Administration Related Reaction (ARR), Grade ≥3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
2
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
3
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
3
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Mucositis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
18
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
8
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
4
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
8
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Interstitial Lung Disease (ILD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
4
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
2
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
3
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
5
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
1
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
12
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
24
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
2
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
0
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
1
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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
Arm A: Treatment With P+H IV (Cycles 1 to 3)
1
Not reported
Not reported
Not reported
Not reported
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
0
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
2
Not reported
Not reported
Not reported
Not reported
Arm B: Treatment With P+H IV (Cycles 4 to 6)
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
62
group Id
OG001
value
60
group Id
OG002
value
62
group Id
OG003
value
51
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
1
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
4
title
Grade 3 to 5 AE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Related Grade 3 to 5 AE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
2
title
Cardiac AE (Including LVEF Events)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
5
title
Serious AE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
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
7
group Id
OG001
value
14
group Id
OG002
value
24
group Id
OG003
value
2
title
Administration Related Reaction (ARR), 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 (ARR), Grade ≥3
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
3
title
Cardiac Dysfunction AE, All Grades
denoms
counts
group Id
OG000
value
80
group Id
OG001
value
80
group Id
OG002
value
80
group Id
OG003
value
80
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 only includes the adverse events that occurred in Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
id
OG000
title
Arm A: Treatment With P+H IV (Cycles 1 to 3)
description
This safety analysis population only includes adverse events that occurred in Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).
id
OG001
title
Arm A: Treatment With PH FDC SC (Cycles 4 to 6)
description
This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
id
OG002
title
Arm B: Treatment With PH FDC SC (Cycles 1 to 3)
description
This safety analysis population only includes adverse events that occurred in Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).
id
OG003
title
Arm B: Treatment With P+H IV (Cycles 4 to 6)
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 study arm and treatment received during the Cross-Over Period.
reporting Status
POSTED
time Frame
From Day 1 of Cycle 1 to the end of Cycle 3 of Cross-Over Period; from Day 1 of Cycle 4 to the end of Cycle 6 of Cross-Over Period (1 cycle is 21 days)
title
Safety Summary for Assessment of Switching Between the FDC SC and IV Formulations: Number of Participants With at Least One Adverse Event During the Treatment Cross-Over Period by Study Arm and Treatment Received
Triangle