Breast Neoplasms
Conditions
Brief summary
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
Interventions
DRUGDocetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
DRUGNab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
DRUGPaclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
DRUGPertuzumab
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
DRUGTrastuzumab
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection * HER2-positive breast cancer * Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * LVEF of at least 50 percent (%)
Exclusion criteria
* Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease * Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months * Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy * Central nervous system (CNS) metastases * Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0) * History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma * Inadequate bone marrow, liver or renal function * Uncontrolled hypertension * Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug. |
| Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal |
| Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal |
| Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented. |
| Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. |
| Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. |
| Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab |
| Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab |
| Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories. |
| Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. |
| Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category. |
| Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. |
| Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. |
| Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. |
| Number of Participants With a Congestive Heart Failure Event | From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1). |
| Time to Onset of the First Episode of Congestive Heart Failure | From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value. |
| Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (\<)10% points or no change in LVEF; 2) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥10% points to \<15% points; 3) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥15% points; or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline; Decr. = decrease; Incr. = increase |
| Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. |
| Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. |
| Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. |
| Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the social well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B social well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
| Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the emotional well-being subscale, participants were given a series of 6 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B emotional well-being subscale score, ranging from 0 to 24, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
| Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the breast cancer subscale, participants were given a series of 10 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B breast cancer subscale score, ranging from 0 to 40, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
| Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the functional well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B functional well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
| Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression. |
| Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Region of Enrollment: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Taxane Chemotherapy: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Visceral Disease at Baseline: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival | From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation. |
| Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. |
| Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Best overall response (BOR) was defined as the best response recorded from the first dose of study treatment until disease progression/recurrence or death in the absence of disease progression. The hierarchy used to determine BOR: Complete Response (CR)\>Partial Response (PR)\>Stable Disease (SD)\>Progressive Disease (PD)\>Not Evaluable. Note that CR or PR was confirmed ≥4 weeks later. RECIST v1.1 responses are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.; PD = At least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study, and absolute increase of ≥5 mm.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. |
| Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders. |
| Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1 | Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | The clinical benefit rate was defined as the percentage of participants whose best confirmed response (≥4 weeks later) was a complete response (CR) or partial response (PR), or stable disease (SD) that lasted at least 6 months, as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Clinical benefit responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least 20% increase in sum of diameters of target lesions and absolute increase of ≥5 mm), taking as reference the smallest sum diameters while on study. |
| Duration of Response as Assessed by the Investigator Using RECIST v1.1 | From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Duration of response (DOR) was defined as the time from when a confirmed best overall response of complete response (CR) or partial response (PR) was first documented to first documented disease progression or death from any cause (whichever occurred first). DOR was analyzed using a Kaplan-Meier approach. Participants who had not progressed or died after having had a confirmed response were censored at the date of their last tumor measurement. Response was assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1 | From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. | Time to response (TTR) was defined as the time from the first study treatment administration to the date of first confirmed response (CR or PR). TTR was analyzed using a Kaplan-Meier approach. Participants who did not have CR or PR were censored at the date of their last evaluable tumor assessment. Participants for whom no post-baseline tumor assessments were available were censored at Day 1. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. Participants were given a series of statements in each subscale and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B total score, ranging from 0 to 148, was the sum of the scores for each subscale, provided that at least 80% of the items had been answered; a higher score indicated a better quality of life. If any of the 5 subscale scores were missing, the total score was also set to missing. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
| Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. | The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the physical well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B physical well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only. |
Countries
Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lebanon, Lithuania, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela
Participant flow
Pre-assignment details
A total of 1697 patients were screened: 261 failed screening and 1436 were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Pertuzumab + Trastuzumab + Taxane Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice. | 1,436 |
| Total | 1,436 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 648 |
| Overall Study | Enrolled into Another Trial | 3 |
| Overall Study | Lost to Follow-up | 81 |
| Overall Study | Participated in Another Trial | 3 |
| Overall Study | Patient Decision | 14 |
| Overall Study | Patient Deterioration | 1 |
| Overall Study | Physician Decision | 20 |
| Overall Study | Progressive Disease | 8 |
| Overall Study | Site Closed Before Completing Form | 6 |
| Overall Study | Sponsor Decision | 1 |
| Overall Study | Termination by Sponsor | 2 |
| Overall Study | Withdrawal by Subject | 204 |
Baseline characteristics
| Characteristic | Pertuzumab + Trastuzumab + Taxane |
|---|---|
| Age Categorical (≤65 or >65 Years Old) ≤65 Years Old | 1167 Participants |
| Age Categorical (≤65 or >65 Years Old) >65 Years Old | 269 Participants |
| Age, Continuous | 54.4 Years STANDARD_DEVIATION 12.1 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline Grade 0 or 1 | 1371 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline Grade 2 | 63 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline Missing | 2 Participants |
| Ethnicity Chinese | 57 Participants |
| Ethnicity Hispanic/Latino | 269 Participants |
| Ethnicity Indian | 21 Participants |
| Ethnicity Japanese | 2 Participants |
| Ethnicity Mixed Ethnicity | 18 Participants |
| Ethnicity Not Applicable as per Local Regulations | 574 Participants |
| Ethnicity Other | 495 Participants |
| Geographic Region of Enrollment Africa | 71 Participants |
| Geographic Region of Enrollment Asia | 177 Participants |
| Geographic Region of Enrollment Europe | 1009 Participants |
| Geographic Region of Enrollment North America | 34 Participants |
| Geographic Region of Enrollment Other (Australia) | 24 Participants |
| Geographic Region of Enrollment South America | 121 Participants |
| Hormone Receptor Status of Disease at Baseline Negative | 512 Participants |
| Hormone Receptor Status of Disease at Baseline Positive | 918 Participants |
| Hormone Receptor Status of Disease at Baseline Unknown | 6 Participants |
| Initial Type of Taxane Received During the Study: Docetaxel, Paclitaxel, or Nab-Paclitaxel Docetaxel | 775 Participants |
| Initial Type of Taxane Received During the Study: Docetaxel, Paclitaxel, or Nab-Paclitaxel Nab-Paclitaxel | 65 Participants |
| Initial Type of Taxane Received During the Study: Docetaxel, Paclitaxel, or Nab-Paclitaxel None | 8 Participants |
| Initial Type of Taxane Received During the Study: Docetaxel, Paclitaxel, or Nab-Paclitaxel Paclitaxel | 588 Participants |
| Measurable or Non-Measurable Disease (per RECIST v1.1) at Baseline Measurable Disease | 1198 Participants |
| Measurable or Non-Measurable Disease (per RECIST v1.1) at Baseline Non-Measurable Disease | 238 Participants |
| Previous Trastuzumab Therapy Received for Breast Cancer No Previous Trastuzumab Therapy | 1036 Participants |
| Previous Trastuzumab Therapy Received for Breast Cancer Previous Trastuzumab Therapy | 400 Participants |
| Prior Neoadjuvant or Adjuvant Chemotherapy Received No Prior (Neo)Adjuvant Chemotherapy | 650 Participants |
| Prior Neoadjuvant or Adjuvant Chemotherapy Received Prior (Neo)Adjuvant Chemotherapy | 786 Participants |
| Race/Ethnicity, Customized Asian | 88 Participants |
| Race/Ethnicity, Customized Black | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 1032 Participants |
| Race/Ethnicity, Customized Native American | 28 Participants |
| Race/Ethnicity, Customized Not Applicable as per Local Regulations | 222 Participants |
| Race/Ethnicity, Customized Other | 57 Participants |
| Sex: Female, Male Female | 1429 Participants |
| Sex: Female, Male Male | 7 Participants |
| Visceral Disease at Baseline Non-visceral Disease | 444 Participants |
| Visceral Disease at Baseline Visceral Disease | 992 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 658 / 1,436 |
| other Total, other adverse events | 1,394 / 1,436 |
| serious Total, serious adverse events | 535 / 1,436 |
Outcome results
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study
All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.
Time frame: Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 81 | -1.8 Percentage points of LVEF | Standard Deviation 6.98 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 64.6 Percentage points of LVEF | Standard Deviation 6.46 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 3 | -1.1 Percentage points of LVEF | Standard Deviation 6.49 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 6 | -1.5 Percentage points of LVEF | Standard Deviation 6.6 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 9 | -2.1 Percentage points of LVEF | Standard Deviation 6.56 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 12 | -1.9 Percentage points of LVEF | Standard Deviation 6.66 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 15 | -2.2 Percentage points of LVEF | Standard Deviation 6.5 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 18 | -1.8 Percentage points of LVEF | Standard Deviation 6.77 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 21 | -1.9 Percentage points of LVEF | Standard Deviation 6.79 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 24 | -1.9 Percentage points of LVEF | Standard Deviation 6.93 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 27 | -2.1 Percentage points of LVEF | Standard Deviation 6.81 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 30 | -1.8 Percentage points of LVEF | Standard Deviation 6.8 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 33 | -1.9 Percentage points of LVEF | Standard Deviation 6.97 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 36 | -2.1 Percentage points of LVEF | Standard Deviation 6.53 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 39 | -2.1 Percentage points of LVEF | Standard Deviation 6.77 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 42 | -1.9 Percentage points of LVEF | Standard Deviation 6.52 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 45 | -2.2 Percentage points of LVEF | Standard Deviation 6.94 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 48 | -2.1 Percentage points of LVEF | Standard Deviation 6.67 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 51 | -1.6 Percentage points of LVEF | Standard Deviation 6.75 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 54 | -1.7 Percentage points of LVEF | Standard Deviation 6.38 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 57 | -1.7 Percentage points of LVEF | Standard Deviation 6.87 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 60 | -1.5 Percentage points of LVEF | Standard Deviation 6.46 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 63 | -1.6 Percentage points of LVEF | Standard Deviation 7.13 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 66 | -2.0 Percentage points of LVEF | Standard Deviation 6.63 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 69 | -1.9 Percentage points of LVEF | Standard Deviation 6.45 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 72 | -2.1 Percentage points of LVEF | Standard Deviation 6.8 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 75 | -1.5 Percentage points of LVEF | Standard Deviation 6.84 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 78 | -1.8 Percentage points of LVEF | Standard Deviation 7.41 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 84 | -1.6 Percentage points of LVEF | Standard Deviation 6.89 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 87 | -1.9 Percentage points of LVEF | Standard Deviation 6.31 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 90 | -1.1 Percentage points of LVEF | Standard Deviation 6.68 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 93 | -1.6 Percentage points of LVEF | Standard Deviation 6.78 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 96 | -1.8 Percentage points of LVEF | Standard Deviation 6.33 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 99 | -2.0 Percentage points of LVEF | Standard Deviation 7.2 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 102 | -2.5 Percentage points of LVEF | Standard Deviation 7.95 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 105 | -2.5 Percentage points of LVEF | Standard Deviation 6.86 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 108 | -1.8 Percentage points of LVEF | Standard Deviation 8.04 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 111 | -3.3 Percentage points of LVEF | Standard Deviation 7.47 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 114 | -1.1 Percentage points of LVEF | Standard Deviation 8.12 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 117 | -5.8 Percentage points of LVEF | Standard Deviation 7.48 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 120 | -8.6 Percentage points of LVEF | Standard Deviation 6.7 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 123 | -9.3 Percentage points of LVEF | Standard Deviation 3.51 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Cycle 126 | -9.0 Percentage points of LVEF | — |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at End of Treatment | -3.8 Percentage points of LVEF | Standard Deviation 8.34 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL at Day 28 of Follow-Up | -3.2 Percentage points of LVEF | Standard Deviation 8.19 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL: Final Treatment Value | -2.0 Percentage points of LVEF | Standard Deviation 6.77 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL: Worst Treatment Value | -7.1 Percentage points of LVEF | Standard Deviation 6.88 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study | Change from BL: Maximum Decrease Value | -7.7 Percentage points of LVEF | Standard Deviation 7.45 |
Primary
Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study
All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (\<)10% points or no change in LVEF; 2) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥10% points to \<15% points; 3) an absolute LVEF value \<45% points and a decrease from baseline LVEF ≥15% points; or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline; Decr. = decrease; Incr. = increase
Time frame: Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 84 | LVEF≥45% Points and Decr. from BL ≥10% Points | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 3 | Incr. or Decr. from BL <10% Points, or No Change | 1190 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 3 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 3 | LVEF<45% Points and Decr. from BL ≥15% Points | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 3 | LVEF≥45% Points and Decr. from BL ≥10% Points | 114 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 6 | Incr. or Decr. from BL <10% Points, or No Change | 1110 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 6 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 6 | LVEF<45% Points and Decr. from BL ≥15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 6 | LVEF≥45% Points and Decr. from BL ≥10% Points | 136 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 9 | Incr. or Decr. from BL <10% Points, or No Change | 1005 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 9 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 9 | LVEF<45% Points and Decr. from BL ≥15% Points | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 9 | LVEF≥45% Points and Decr. from BL ≥10% Points | 139 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 12 | Incr. or Decr. from BL <10% Points, or No Change | 906 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 12 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 12 | LVEF<45% Points and Decr. from BL ≥15% Points | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 12 | LVEF≥45% Points and Decr. from BL ≥10% Points | 116 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 15 | Incr. or Decr. from BL <10% Points, or No Change | 780 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 15 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 15 | LVEF<45% Points and Decr. from BL ≥15% Points | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 15 | LVEF≥45% Points and Decr. from BL ≥10% Points | 109 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 18 | Incr. or Decr. from BL <10% Points, or No Change | 719 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 18 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 18 | LVEF<45% Points and Decr. from BL ≥15% Points | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 18 | LVEF≥45% Points and Decr. from BL ≥10% Points | 92 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 21 | Incr. or Decr. from BL <10% Points, or No Change | 639 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 21 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 21 | LVEF<45% Points and Decr. from BL ≥15% Points | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 21 | LVEF≥45% Points and Decr. from BL ≥10% Points | 88 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 24 | Incr. or Decr. from BL <10% Points, or No Change | 588 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 24 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 24 | LVEF<45% Points and Decr. from BL ≥15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 24 | LVEF≥45% Points and Decr. from BL ≥10% Points | 91 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 27 | Incr. or Decr. from BL <10% Points, or No Change | 553 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 27 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 27 | LVEF<45% Points and Decr. from BL ≥15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 27 | LVEF≥45% Points and Decr. from BL ≥10% Points | 78 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 30 | Incr. or Decr. from BL <10% Points, or No Change | 518 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 30 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 30 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 30 | LVEF≥45% Points and Decr. from BL ≥10% Points | 70 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 33 | Incr. or Decr. from BL <10% Points, or No Change | 485 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 33 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 33 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 33 | LVEF≥45% Points and Decr. from BL ≥10% Points | 72 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 36 | Incr. or Decr. from BL <10% Points, or No Change | 446 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 36 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 36 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 36 | LVEF≥45% Points and Decr. from BL ≥10% Points | 62 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 39 | Incr. or Decr. from BL <10% Points, or No Change | 414 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 39 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 39 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 39 | LVEF≥45% Points and Decr. from BL ≥10% Points | 65 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 42 | Incr. or Decr. from BL <10% Points, or No Change | 405 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 42 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 42 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 42 | LVEF≥45% Points and Decr. from BL ≥10% Points | 46 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 45 | Incr. or Decr. from BL <10% Points, or No Change | 358 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 45 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 45 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 45 | LVEF≥45% Points and Decr. from BL ≥10% Points | 69 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 48 | Incr. or Decr. from BL <10% Points, or No Change | 340 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 48 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 48 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 48 | LVEF≥45% Points and Decr. from BL ≥10% Points | 49 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 51 | Incr. or Decr. from BL <10% Points, or No Change | 314 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 51 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 51 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 51 | LVEF≥45% Points and Decr. from BL ≥10% Points | 43 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 54 | Incr. or Decr. from BL <10% Points, or No Change | 292 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 54 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 54 | LVEF<45% Points and Decr. from BL ≥15% Points | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 54 | LVEF≥45% Points and Decr. from BL ≥10% Points | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 57 | Incr. or Decr. from BL <10% Points, or No Change | 291 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 57 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 57 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 57 | LVEF≥45% Points and Decr. from BL ≥10% Points | 41 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 60 | Incr. or Decr. from BL <10% Points, or No Change | 284 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 60 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 60 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 60 | LVEF≥45% Points and Decr. from BL ≥10% Points | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 63 | Incr. or Decr. from BL <10% Points, or No Change | 263 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 63 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 63 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 63 | LVEF≥45% Points and Decr. from BL ≥10% Points | 39 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 66 | Incr. or Decr. from BL <10% Points, or No Change | 249 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 66 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 66 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 66 | LVEF≥45% Points and Decr. from BL ≥10% Points | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 69 | Incr. or Decr. from BL <10% Points, or No Change | 237 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 69 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 69 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 69 | LVEF≥45% Points and Decr. from BL ≥10% Points | 33 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 72 | Incr. or Decr. from BL <10% Points, or No Change | 224 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 72 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 72 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 72 | LVEF≥45% Points and Decr. from BL ≥10% Points | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 75 | Incr. or Decr. from BL <10% Points, or No Change | 224 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 75 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 75 | LVEF<45% Points and Decr. from BL ≥15% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 75 | LVEF≥45% Points and Decr. from BL ≥10% Points | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 78 | Incr. or Decr. from BL <10% Points, or No Change | 214 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 78 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 78 | LVEF<45% Points and Decr. from BL ≥15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 78 | LVEF≥45% Points and Decr. from BL ≥10% Points | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 81 | Incr. or Decr. from BL <10% Points, or No Change | 196 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 81 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 81 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 81 | LVEF≥45% Points and Decr. from BL ≥10% Points | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 84 | Incr. or Decr. from BL <10% Points, or No Change | 192 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 84 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 84 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 87 | Incr. or Decr. from BL <10% Points, or No Change | 174 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 87 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 87 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 87 | LVEF≥45% Points and Decr. from BL ≥10% Points | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 90 | Incr. or Decr. from BL <10% Points, or No Change | 161 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 90 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 90 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 90 | LVEF≥45% Points and Decr. from BL ≥10% Points | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 93 | Incr. or Decr. from BL <10% Points, or No Change | 140 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 93 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 93 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 93 | LVEF≥45% Points and Decr. from BL ≥10% Points | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 96 | Incr. or Decr. from BL <10% Points, or No Change | 115 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 96 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 96 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 96 | LVEF≥45% Points and Decr. from BL ≥10% Points | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 99 | Incr. or Decr. from BL <10% Points, or No Change | 92 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 99 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 99 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 99 | LVEF≥45% Points and Decr. from BL ≥10% Points | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 102 | Incr. or Decr. from BL <10% Points, or No Change | 68 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 102 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 102 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 102 | LVEF≥45% Points and Decr. from BL ≥10% Points | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 105 | Incr. or Decr. from BL <10% Points, or No Change | 56 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 105 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 105 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 105 | LVEF≥45% Points and Decr. from BL ≥10% Points | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 108 | Incr. or Decr. from BL <10% Points, or No Change | 41 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 108 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 108 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 108 | LVEF≥45% Points and Decr. from BL ≥10% Points | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 111 | Incr. or Decr. from BL <10% Points, or No Change | 34 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 111 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 111 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 111 | LVEF≥45% Points and Decr. from BL ≥10% Points | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 114 | Incr. or Decr. from BL <10% Points, or No Change | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 114 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 114 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 114 | LVEF≥45% Points and Decr. from BL ≥10% Points | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 117 | Incr. or Decr. from BL <10% Points, or No Change | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 117 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 117 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 117 | LVEF≥45% Points and Decr. from BL ≥10% Points | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 120 | Incr. or Decr. from BL <10% Points, or No Change | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 120 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 120 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 120 | LVEF≥45% Points and Decr. from BL ≥10% Points | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 123 | Incr. or Decr. from BL <10% Points, or No Change | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 123 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 123 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 123 | LVEF≥45% Points and Decr. from BL ≥10% Points | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 126 | Incr. or Decr. from BL <10% Points, or No Change | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 126 | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 126 | LVEF<45% Points and Decr. from BL ≥15% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Cycle 126 | LVEF≥45% Points and Decr. from BL ≥10% Points | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | End of Treatment | Incr. or Decr. from BL <10% Points, or No Change | 431 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | End of Treatment | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | End of Treatment | LVEF<45% Points and Decr. from BL ≥15% Points | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | End of Treatment | LVEF≥45% Points and Decr. from BL ≥10% Points | 87 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Day 28 of Follow-Up | Incr. or Decr. from BL <10% Points, or No Change | 472 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Day 28 of Follow-Up | LVEF<45% Points and Decr. from BL ≥10%-<15% Points | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Day 28 of Follow-Up | LVEF<45% Points and Decr. from BL ≥15% Points | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study | Day 28 of Follow-Up | LVEF≥45% Points and Decr. from BL ≥10% Points | 86 Participants |
Primary
Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
Time frame: The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pancreatitis Chronic (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatic Encephalopathy (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Total Number of Deaths | 658 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Progressive Disease | 581 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Other | 42 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Adverse Event (Total) | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Infections and Infestations (SOC) | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Peritonitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pneumonia (PT) | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Respiratory Tract Infection (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Sepsis (PT) | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Septic Shock (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Disorders (SOC) | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Arrest (PT) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Failure (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Failure Congestive (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardio-respiratory Arrest (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Myocardial Infarction (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Right Ventricular Failure (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | General Disorders & Admin. Site Conditions (SOC) | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Death (PT) | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Blood and Lymphatic System Disorders (SOC) | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Febrile Neutropenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Neutropenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Thrombocytopenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Respiratory, Thoracic & Mediast. Disorders (SOC) | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Acute Respiratory Distress Syndrome (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Aspiration (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pneumonitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Gastrointestinal Disorders (SOC) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pancreatitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Nervous System Disorders (SOC) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Ischemic Stroke (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Metabolism and Nutrition Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hypoglycaemia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatobiliary Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatic Failure (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Psychiatric Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Delirium (PT) | 1 Participants |
Primary
Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term)
All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
Time frame: The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Total Number of Deaths | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Progressive Disease | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Other | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Number of Deaths by Cause: Adverse Event (Total) | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Infections and Infestations (SOC) | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Peritonitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pneumonia (PT) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Respiratory Tract Infection (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Sepsis (PT) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | General Disorders & Admin. Site Conditions (SOC) | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Death (PT) | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Blood and Lymphatic System Disorders (SOC) | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Febrile Neutropenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Neutropenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Thrombocytopenia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Disorders (SOC) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardiac Arrest (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Cardio-Respiratory Arrest (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Respiratory, Thoracic & Mediast. Disorders (SOC) | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Acute Respiratory Distress Syndrome (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pneumonitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Gastrointestinal Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Pancreatitis (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Nervous System Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatic Encephalopathy (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Metabolism and Nutrition Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hypoglycaemia (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatobiliary Disorders (SOC) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) | Hepatic Failure (PT) | 1 Participants |
Primary
Number of Participants With a Congestive Heart Failure Event
Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).
Time frame: From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With a Congestive Heart Failure Event | 478 Participants |
Primary
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Device Related Infection (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pulmonary Embolism (PT) - Gr. 3 | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutropenia (PT) - Gr. 3 | 77 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Anaemia (PT) - Gr. 3 | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Leukopenia (PT) - Gr. 3 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Ejection Fraction Decreased (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gamma-Glutamyltransferase Increased (PT) - Gr. 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Any TEAE - Grade (Gr.) 3 | 676 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Any TEAE - Gr. 4 | 172 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Any TEAE - Gr. 5 | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gastrointestinal Disorders (SOC) - Gr. 3 | 163 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gastrointestinal Disorders (SOC) - Gr. 4 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gastrointestinal Disorders (SOC) - Gr. 5 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Diarrhoea (PT) - Gr. 3 | 119 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Diarrhoea (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Diarrhoea (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vomiting (PT) - Gr. 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vomiting (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vomiting (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Skin & Subcutaneous Tissue Disorders (SOC) - Gr. 3 | 56 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Skin & Subcutaneous Tissue Disorders (SOC) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Skin & Subcutaneous Tissue Disorders (SOC) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gen. Disorders & Admin.Site Conditions (SOC)-Gr. 3 | 100 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gen. Disorders & Admin.Site Conditions (SOC)-Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gen. Disorders & Admin.Site Conditions (SOC)-Gr. 5 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Fatigue (PT) - Gr. 3 | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Fatigue (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Fatigue (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Asthenia (PT) - Gr. 3 | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Asthenia (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Asthenia (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Mucosal Inflammation (PT) - Gr. 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Mucosal Inflammation (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Mucosal Inflammation (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Nervous System Disorders (SOC) - Gr. 3 | 139 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Nervous System Disorders (SOC) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Nervous System Disorders (SOC) - Gr. 5 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neuropathy Peripheral (PT) - Gr. 3 | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neuropathy Peripheral (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neuropathy Peripheral (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Syncope (PT) - Gr. 3 | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Syncope (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Syncope (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Headache (PT) - Gr. 3 | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Headache (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Headache (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Paraesthesia (PT) - Gr. 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Paraesthesia (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Paraesthesia (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Peripheral Sensory Neuropathy (PT) - Gr. 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Peripheral Sensory Neuropathy (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Peripheral Sensory Neuropathy (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Infections and Infestations (SOC) - Gr. 3 | 148 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Infections and Infestations (SOC) - Gr. 4 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Infections and Infestations (SOC) - Gr. 5 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pneumonia (PT) - Gr. 3 | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pneumonia (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pneumonia (PT) - Gr. 5 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Device Infection (PT) - Gr. 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Device Infection (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Device Infection (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Device Related Infection (PT) - Gr. 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Device Related Infection (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Musculo. & Connective Tissue Disorders (SOC)-Gr. 3 | 75 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Musculo. & Connective Tissue Disorders (SOC)-Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Musculo. & Connective Tissue Disorders (SOC)-Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Resp., Thoracic & Mediast. Disorders (SOC) - Gr. 3 | 62 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Resp., Thoracic & Mediast. Disorders (SOC) - Gr. 4 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Resp., Thoracic & Mediast. Disorders (SOC) - Gr. 5 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pulmonary Embolism (PT) - Gr. 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Pulmonary Embolism (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Dyspnoea (PT) - Gr. 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Dyspnoea (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Dyspnoea (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Blood & Lymphatic System Disorders (SOC) - Gr. 3 | 158 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Blood & Lymphatic System Disorders (SOC) - Gr. 4 | 104 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Blood & Lymphatic System Disorders (SOC) - Gr. 5 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutropenia (PT) - Gr. 4 | 67 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutropenia (PT) - Gr. 5 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Febrile Neutropenia (PT) - Gr. 3 | 51 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Febrile Neutropenia (PT) - Gr. 4 | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Febrile Neutropenia (PT) - Gr. 5 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Anaemia (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Anaemia (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Leukopenia (PT) - Gr. 4 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Leukopenia (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Investigations (SOC) - Gr. 3 | 116 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Investigations (SOC) - Gr. 4 | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Investigations (SOC) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutrophil Count Decreased (PT) - Gr. 3 | 25 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutrophil Count Decreased (PT) - Gr. 4 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neutrophil Count Decreased (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Ejection Fraction Decreased (PT) - Gr. 3 | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Ejection Fraction Decreased (PT) - Gr. 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gamma-Glutamyltransferase Increased (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Gamma-Glutamyltransferase Increased (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | White Blood Cell Count Decreased (PT) - Gr. 3 | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | White Blood Cell Count Decreased (PT) - Gr. 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | White Blood Cell Count Decreased (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Alanine Aminotransferase Increased (PT) - Gr. 3 | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Alanine Aminotransferase Increased (PT) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Alanine Aminotransferase Increased (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Metabolism and Nutrition Disorders (SOC) - Gr. 3 | 63 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Metabolism and Nutrition Disorders (SOC) - Gr. 4 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Metabolism and Nutrition Disorders (SOC) - Gr. 5 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypokalaemia (PT) - Gr. 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypokalaemia (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypokalaemia (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Disorders (SOC) - Gr. 3 | 62 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Disorders (SOC) - Gr. 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Vascular Disorders (SOC) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypertension (PT) - Gr. 3 | 45 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypertension (PT) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hypertension (PT) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Psychiatric Disorders (SOC) - Gr. 3 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Psychiatric Disorders (SOC) - Gr. 4 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Psychiatric Disorders (SOC) - Gr. 5 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Injury, Poisoning & Proced. Complicat. (SOC)-Gr. 3 | 43 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Injury, Poisoning & Proced. Complicat. (SOC)-Gr. 4 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Injury, Poisoning & Proced. Complicat. (SOC)-Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Cardiac Disorders (SOC) - Gr. 3 | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Cardiac Disorders (SOC) - Gr. 4 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Cardiac Disorders (SOC) - Gr. 5 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Immune System Disorders (SOC) - Gr. 3 | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Immune System Disorders (SOC) - Gr. 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Immune System Disorders (SOC) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Renal and Urinary Disorders (SOC) - Gr. 3 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Renal and Urinary Disorders (SOC) - Gr. 4 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Renal and Urinary Disorders (SOC) - Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neoplasms Benign, Malignant & Unspec. (SOC) -Gr. 3 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neoplasms Benign, Malignant & Unspec. (SOC) -Gr. 4 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Neoplasms Benign, Malignant & Unspec. (SOC) -Gr. 5 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hepatobiliary Disorders (SOC) - Gr. 3 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hepatobiliary Disorders (SOC) - Gr. 4 | 0 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term | Hepatobiliary Disorders (SOC) - Gr. 5 | 1 Participants |
Primary
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Cardiac Failure | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Febrile Neutropenia | 86 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any Grade ≥3 TEAE Related to Pertuz. (Rel to Ptz) | 286 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Diarrhoea | 59 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Neutropenia | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Febrile Neutropenia | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Ejection Fraction Decreased | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Neutrophil Count Decreased | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Fatigue | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Left Ventricular Dysfunction | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Asthenia | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: White Blood Cell Count Decreased | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Ptz: Cardiac Failure | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any Grade ≥3 TEAE Related to Trastuz. (Rel to Trz) | 245 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Diarrhoea | 32 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Neutropenia | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Ejection Fraction Decreased | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Febrile Neutropenia | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Neutrophil Count Decreased | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Fatigue | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Left Ventricular Dysfunction | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: White Blood Cell Count Decreased | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Trz: Asthenia | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any Grade ≥3 TEAE Related to Taxane (Rel to Tax) | 514 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Neutropenia | 140 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Diarrhoea | 80 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Neutrophil Count Decreased | 34 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Fatigue | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Peripheral Neuropathy | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Asthenia | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Leukopenia | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: White Blood Cell Count Decreased | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Mucosal Inflammation | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Paraesthesia | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Peripheral Sensory Neuropathy | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Onycholysis | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Neutropenic Sepsis | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Anaemia | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Vomiting | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Rel to Tax: Neurotoxicity | 7 Participants |
Primary
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Mucosal Inflammation (PT) | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Any Grade ≥3 TEAE to Monitor | 535 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Neutropenia/Febrile Neutropenia (Category) | 279 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Neutropenia (PT) | 145 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Febrile Neutropenia (PT) | 90 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Neutrophil Count Decreased (PT) | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Leukopenia (PT) | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | White Blood Cell Count Decreased (PT) | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Neutropenic Sepsis (PT) | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Infusion-/Admin.-Related Reactions (Category) | 123 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Hypertension (PT) | 27 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | IRR/ARR: Drug Hypersensitivity (PT) | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Asthenia (PT) | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Fatigue (PT) | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Dyspnoea (PT) | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Infusion Related Reaction (PT) | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Paraesthesia (PT) | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Diarrhoea Grade ≥3 (Category) | 120 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Diarrhoea (PT) | 120 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Cardiac Dysfunction (Category) | 51 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Ejection Fraction Decreased (PT) | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Left Ventricular Dysfunction (PT) | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Cardiac Failure (PT) | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Mucositis (Category) | 33 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Stomatitis (PT) | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Rash/Skin Reactions (Category) | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Rash (PT) | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Anaphylaxis and Hypersensitivity (Category) | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term | Anaphyl./Hypersens.: Drug Hypersensitivity (PT) | 13 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Time frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 2 to 2 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 2 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Missing to Normal | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Missing to Grade 2 | 40 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Missing to Missing | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Normal | 1061 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 4 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Missing to Normal | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 1 to 1 | 120 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Normal to Normal | 610 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Normal to Grade 1 | 425 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Normal to Grade 2 | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Normal to Grade 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Normal to Missing | 25 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 1 to Normal | 75 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 1 to 1 | 151 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 1 to 2 | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 1 to 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 1 to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 2 to Normal | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 2 to 1 | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 2 to 2 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 2 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Grade 3 to 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Missing to Normal | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Missing to Grade 1 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Missing to Grade 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alanine Aminotransferase: Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Normal to Normal | 562 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Normal to Grade 1 | 386 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Normal to Grade 2 | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Normal to Grade 3 | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Normal to Missing | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 1 to Normal | 120 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 1 to 1 | 187 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 1 to 2 | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 1 to 3 | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 1 to Missing | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 2 to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 2 to 1 | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 2 to 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 2 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 3 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 3 to 1 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Grade 3 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Missing to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Missing to Grade 1 | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Missing to Grade 2 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Aspartate Aminotransferase: Missing to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Normal to Normal | 785 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Normal to Grade 1 | 357 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Normal to Grade 2 | 86 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Normal to Grade 3 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Normal to Missing | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 1 to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 1 to 1 | 43 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 1 to 2 | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 1 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 1 to Missing | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 2 to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 2 to 1 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 2 to 2 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 2 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 2 to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 3 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Grade 3 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Missing to Normal | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Missing to Grade 1 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Missing to Grade 2 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Albumin: Missing to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Normal to Normal | 605 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Normal to Grade 1 | 329 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Normal to Grade 2 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Normal to Grade 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Normal to Missing | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 1 to Normal | 44 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 1 to 1 | 241 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 1 to 2 | 72 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 1 to 3 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 1 to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 2 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 2 to 1 | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 2 to 2 | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 2 to 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 2 to Missing | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 3 to 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 3 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Grade 3 to 3 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Missing to Normal | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Missing to Grade 1 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Alkaline Phosphatase: Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Normal | 1060 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Grade 1 | 192 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Grade 2 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Grade 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Normal to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 1 to Normal | 47 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 1 to 1 | 47 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 1 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 1 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 1 to Missing | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 2 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 2 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 2 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 3 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 3 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 3 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Grade 4 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Missing to Normal | 32 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Missing to Grade 1 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (High): Missing to Missing | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Normal to Normal | 786 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Normal to Grade 1 | 378 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Normal to Grade 2 | 117 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Normal to Grade 3 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Normal to Missing | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 1 to Normal | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 1 to 1 | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 1 to 2 | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 1 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 1 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 2 to Normal | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 2 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 2 to 2 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Grade 3 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Missing to Normal | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Missing to Grade 1 | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Missing to Grade 2 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Calcium (Low): Missing to Missing | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Normal | 176 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Grade 1 | 960 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Grade 2 | 175 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Grade 3 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Grade 4 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Normal to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 1 to Normal | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 1 to 1 | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 1 to 2 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 1 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 2 to 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 2 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Grade 2 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Missing to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Missing to Grade 1 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Creatinine: Missing to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Normal to Normal | 498 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Normal to Grade 1 | 227 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Normal to Grade 2 | 39 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Normal to Grade 3 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Normal to Missing | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 1 to Normal | 64 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 1 to 1 | 187 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 1 to 2 | 75 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 1 to 3 | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 1 to Missing | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 2 to Normal | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 2 to 1 | 52 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 2 to 2 | 45 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 2 to 3 | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 2 to Missing | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 3 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 3 to 1 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 3 to 2 | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 3 to 3 | 47 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Grade 3 to Missing | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Missing to Normal | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Missing to Grade 1 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Missing to Grade 2 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Missing to Grade 3 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Gamma-Glutamyl Transpeptidase: Missing to Missing | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Normal to Normal | 340 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Normal to Grade 1 | 534 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Normal to Grade 2 | 115 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Normal to Missing | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 1 to Normal | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 1 to 1 | 190 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 1 to 2 | 74 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 1 to Missing | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Missing to Grade 1 | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Grade 1 | 173 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 2 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (High): Grade 2 to 1 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 1 to 1 | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 1 to 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 1 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 1 to 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 2 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Missing to Normal | 69 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Missing to Grade 1 | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Missing to Grade 2 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Missing to Missing | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Normal to Normal | 1100 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Normal to Grade 1 | 122 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Normal to Grade 3 | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Normal to Grade 4 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Normal to Missing | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 1 to Normal | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 1 to 1 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 3 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 3 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Grade 4 to 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Missing to Normal | 85 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Missing to Grade 1 | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Missing to Grade 3 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (High): Missing to Missing | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Grade 1 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Grade 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Grade 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Missing | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Normal | 1051 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Grade 1 | 183 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Grade 2 | 81 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Grade 3 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Grade 4 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Normal to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 1 to Normal | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 1 to 1 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 1 to 2 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 1 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 1 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 2 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 2 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 2 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Grade 4 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Missing to Normal | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Missing to Grade 1 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Missing to Grade 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (High): Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Normal to Normal | 990 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Normal to Grade 2 | 367 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Normal to Missing | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Grade 2 to Normal | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Grade 2 to 2 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Missing to Grade 2 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Potassium (Low): Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Normal | 1075 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Grade 1 | 256 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Grade 2 | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Grade 3 | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Grade 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Normal to Missing | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 1 to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 1 to 1 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 1 to 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 1 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 2 to 2 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 2 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 3 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Grade 3 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Missing to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Missing to Grade 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (High): Missing to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Normal to Normal | 994 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Normal to Grade 1 | 298 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Normal to Grade 3 | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Normal to Grade 4 | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Normal to Missing | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 1 to Normal | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 1 to 1 | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 1 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 1 to 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 1 to Missing | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 3 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 3 to 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 3 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 4 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Grade 4 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Missing to Normal | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Missing to Grade 1 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Sodium (Low): Missing to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Normal to Normal | 1231 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Normal to Grade 1 | 88 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Normal to Grade 2 | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Normal to Grade 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Normal to Missing | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 1 to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 1 to 1 | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 1 to 2 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 1 to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 2 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 2 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 2 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Grade 3 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Missing to Normal | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Missing to Grade 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Total Bilirubin: Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Normal to Normal | 933 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Normal to Grade 1 | 190 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Normal to Grade 4 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Normal to Missing | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 1 to Normal | 58 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 1 to 4 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 1 to Missing | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 4 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 4 to 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 4 to 4 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Grade 4 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Missing to Normal | 57 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Missing to Grade 1 | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Missing to Grade 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Uric Acid: Missing to Missing | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Normal | 857 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Grade 1 | 319 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Grade 2 | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Grade 3 | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Grade 4 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Normal to Missing | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 1 to Normal | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 1 to 1 | 55 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 1 to 2 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 1 to 3 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 1 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Grade 4 to 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Magnesium (Low): Missing to Normal | 81 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Grade 2 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Grade 3 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Grade 4 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Normal to Missing | 33 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Glucose (Low): Grade 1 to Normal | 8 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Time frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Normal to High | 508 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Low to Low | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Missing to Normal | 60 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Normal to Normal | 717 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Normal to Low | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Normal to High | 402 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Normal to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Low to Normal | 69 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Low to Low | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Low to High | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): High to Normal | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): High to High | 98 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Missing to Normal | 42 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Missing to High | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (High): Missing to Missing | 39 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Normal to Normal | 828 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Normal to Low | 293 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Normal to High | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Normal to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Low to Normal | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Low to Low | 72 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): High to Normal | 104 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): High to Low | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): High to High | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Missing to Normal | 47 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Missing to Low | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Missing to High | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Blood Urea Nitrogen (Low): Missing to Missing | 39 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Normal to Normal | 540 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Normal to Low | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Normal to High | 201 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance(High): Normal to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Low to Normal | 166 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Low to Low | 107 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Low to High | 34 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Low to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): High to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): High to High | 101 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance(High): Missing to Normal | 46 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Missing to Low | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (High): Missing to High | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance(High):Missing to Missing | 195 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Normal to Normal | 393 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Normal to Low | 353 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Normal to High | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Low to Normal | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Low to Low | 294 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Missing to High | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Low to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Low to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Missing to Missing | 32 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Normal to Normal | 530 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Normal to Low | 691 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Low to Normal | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): High to Normal | 61 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): High to Low | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Low to Low | 82 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): High to Normal | 41 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): High to Low | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Missing to Normal | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Missing to Low | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): High to High | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Missing to Normal | 66 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (Low): Missing to Missing | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Missing to Low | 44 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance (Low): Missing to High | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Calc Creatinine Clearance(Low): Missing to Missing | 133 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Normal to Normal | 665 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Normal to Low | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Low to Normal | 54 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Low to High | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): High to Normal | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): High to High | 58 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Missing to Normal | 41 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Missing to High | 32 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (High): Missing to Missing | 59 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Normal to Normal | 971 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Normal to Low | 201 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Normal to High | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Low to Normal | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): High to Normal | 57 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): High to Low | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): High to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Missing to Low | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Missing to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Chloride (Low): Missing to Missing | 58 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Normal to Normal | 328 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Normal to High | 499 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Low to Normal | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Low to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Low to High | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): High to Normal | 74 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): High to High | 449 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Missing to Normal | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Missing to High | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (High): Missing to Missing | 25 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Normal to Normal | 716 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Normal to Low | 102 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Normal to High | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Low to Normal | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Low to Low | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Low to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): High to Normal | 426 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): High to Low | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): High to High | 66 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Missing to Normal | 39 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Missing to Low | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Missing to High | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Lactate Dehydrogenase (Low): Missing to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Normal to Normal | 1091 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Normal to Low | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Normal to High | 110 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Low to Normal | 72 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Low to Low | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): High to Normal | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): High to High | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Missing to Normal | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Total Protein (High): Missing to Low | 3 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0
Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Time frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Missing to Normal | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Missing to Grade 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Grade 2 | 190 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Normal | 844 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Grade 1 | 232 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Grade 2 | 169 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Grade 3 | 45 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Grade 4 | 27 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Normal to Missing | 27 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Grade 1 to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Grade 1 to 1 | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Grade 1 to 2 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Grade 1 to 3 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Grade 2 to 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Missing to Normal | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Missing to Grade 1 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Missing to Grade 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Missing to Grade 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Absolute Neutrophil Count: Missing to Missing | 32 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Normal to Normal | 1327 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Normal to Grade 1 | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Normal to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Normal to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Grade 1 to Normal | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Grade 1 to 1 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Grade 1 to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Grade 2 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Missing to Normal | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (High): Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Normal to Normal | 257 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Normal to Grade 1 | 648 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Normal to Grade 2 | 198 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Normal to Grade 3 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Normal to Missing | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 1 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 1 to 1 | 109 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 1 to 2 | 128 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 1 to 3 | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 1 to Missing | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 2 to 1 | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 2 to 2 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 2 to 3 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 2 to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Grade 3 to 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Missing to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Missing to Grade 1 | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Missing to Grade 2 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Hemoglobin (Low): Missing to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Normal to Normal | 1251 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Normal to Grade 2 | 111 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Normal to Grade 3 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Normal to Missing | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Grade 2 to Normal | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Grade 2 to 2 | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Grade 2 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Grade 3 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Grade 3 to 3 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Missing to Grade 2 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (High): Missing to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Normal | 565 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Grade 1 | 255 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Grade 2 | 210 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Grade 3 | 76 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Grade 4 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Normal to Missing | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to 1 | 54 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to 2 | 51 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to 3 | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to 4 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 1 to Missing | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to Normal | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to 1 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to 2 | 37 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to 3 | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 2 to 4 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 3 to 1 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 3 to 2 | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 3 to 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 3 to 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 3 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 4 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 4 to 3 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 4 to 4 | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Grade 4 to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Missing to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Missing to Grade 1 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Lymphocytes (Low): Missing to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Normal to Normal | 1222 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Normal to Grade 1 | 149 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Normal to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Normal to Grade 4 | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Normal to Missing | 26 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Grade 1 to Normal | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Grade 1 to 1 | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Grade 1 to 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Grade 1 to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Missing to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | Platelet Count: Missing to Grade 1 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (High): Normal to Normal | 1391 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (High): Normal to Missing | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (High): Missing to Normal | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (High): Missing to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Normal | 702 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Grade 1 | 392 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Grade 3 | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Grade 4 | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Normal to Missing | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 1 to Normal | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 1 to 1 | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 1 to 2 | 33 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 1 to 3 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 2 to Normal | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 2 to 1 | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 2 to 2 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 3 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Grade 3 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Missing to Normal | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Missing to Grade 1 | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Missing to Grade 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Missing to Grade 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | White Blood Cells (Low): Missing to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Normal to Normal | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Normal to Grade 1 | 52 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Normal to Grade 2 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Normal to Missing | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Grade 1 to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Grade 2 to 3 | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Missing to Normal | 424 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Missing to Grade 1 | 615 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Missing to Grade 2 | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Missing to Grade 3 | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 | International Normalized Ratio: Missing to Missing | 285 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria
Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
Time frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Normal to High | 261 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): High to High | 35 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Low to Low | 97 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Normal to High | 365 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Low to Low | 70 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Missing to Missing | 45 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Normal to High | 283 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Low to Normal | 66 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Low to Low | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Low to High | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): High to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Missing to Normal | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Missing to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Missing to High | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Missing to Missing | 50 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Normal to Normal | 810 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Normal to Low | 390 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Low to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Low to Low | 101 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Low to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): High to Normal | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): High to Low | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): High to High | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Missing to Normal | 37 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Missing to Low | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (Low): Missing to Missing | 28 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Normal to Normal | 953 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Normal to Low | 47 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Normal to High | 58 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Normal to Missing | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Low to Normal | 201 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Low to High | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Low to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): High to Normal | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): High to High | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Missing to Normal | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Missing to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (High): Missing to Missing | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Normal to Normal | 223 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Normal to Low | 837 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Normal to Missing | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Low to Normal | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Low to Low | 305 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): High to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): High to Low | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Missing to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Missing to Low | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Hematocrit (Low): Missing to Missing | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Normal to Normal | 802 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Normal to Low | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Low to Normal | 58 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Low to Low | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Low to High | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): High to Normal | 29 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): High to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): High to High | 82 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Missing to Normal | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Missing to High | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (High): Missing to Missing | 53 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Normal to Normal | 747 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Normal to Low | 420 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Normal to High | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Low to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): High to Normal | 64 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): High to Low | 40 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): High to High | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Missing to Normal | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Missing to Low | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Monocytes (Low): Missing to High | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Normal to Normal | 975 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Normal to Low | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Normal to High | 111 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Low to Normal | 131 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Low to Low | 61 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Low to High | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): High to Normal | 22 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): High to High | 45 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Missing to Normal | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Missing to Low | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Missing to High | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (High): Missing to Missing | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Normal to Normal | 350 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Normal to Low | 767 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Low to Normal | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Low to Low | 197 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): High to Normal | 44 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): High to Low | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): High to High | 2 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Missing to Normal | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Missing to Low | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Red Blood Cells (Low): Missing to Missing | 23 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Normal to Normal | 46 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Normal to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Normal to High | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Low to Normal | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Low to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Low to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): High to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Missing to Normal | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Missing to Low | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Missing to High | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (High): Missing to Missing | 1319 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Normal to Normal | 46 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Normal to Low | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Low to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Low to Low | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): High to Normal | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Missing to Normal | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Missing to Low | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Missing to High | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | PTT (Low): Missing to Missing | 1321 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Normal to Normal | 1020 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Normal to Low | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Low to Normal | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Low to Low | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Low to High | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): High to Normal | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): High to High | 38 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Missing to Normal | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Missing to High | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (High): Missing to Missing | 53 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Normal to Normal | 1206 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Normal to Low | 77 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Normal to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Low to Normal | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Low to Low | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Low to Missing | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): High to Normal | 36 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): High to Low | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): High to High | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Missing to Normal | 40 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Missing to Low | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Missing to High | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Basophils (Low): Missing to Missing | 37 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Normal to Normal | 904 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria | Eosinophils (High): Normal to Low | 13 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Sepsis | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Any TEAE, Pertuzumab Discontinuation (Ptz Discont) | 140 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Ejection Fraction Decreased | 37 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Cardiac Failure | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Left Ventricular Dysfunction | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Diarrhoea | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Dyspnoea | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Infusion Related Reaction | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Neuropathy Peripheral | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: Hypersensitivity | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Ptz Discont: General Physical Health Deterioration | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Any TEAE, Trastuzumab Discontinuation(Trz Discont) | 133 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Ejection Fraction Decreased | 37 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Cardiac Failure | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Left Ventricular Dysfunction | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Diarrhoea | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Sepsis | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Dyspnoea | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Neuropathy Peripheral | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: Hypersensitivity | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Trz Discont: General Physical Health Deterioration | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Any TEAE, Taxane Discontinuation (Tax Discont) | 286 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Neuropathy Peripheral | 52 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Peripheral Sensory Neuropathy | 25 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Paraesthesia | 24 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Diarrhoea | 19 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Fatigue | 16 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Asthenia | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Onycholysis | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Nail Toxicity | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Neurotoxicity | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Polyneuropathy | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Oedema Peripheral | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Febrile Neutropenia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Neutropenia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Dyspnoea | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Decreased Appetite | 6 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Ejection Fraction Decreased | 5 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: General Physical Health Deterioration | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Mucosal Inflammation | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Rash | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Anaemia | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Arthralgia | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Drug Hypersensitivity | 4 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Dysgeusia | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Nail Disorder | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Nail Dystrophy | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Skin Toxicity | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Pneumonia | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Sepsis | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Pleural Effusion | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Pneumonitis | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Cardiac Failure | 3 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term | Tax Discont: Myalgia | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Neutrophil Count Decreased | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Ejection Fraction Decreased | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Neuropathy Peripheral | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Nasopharyngitis | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Drug Hypersensitivity | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Fatigue | 10 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Upper Respiratory Tract Infection | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Infusion Related Reaction | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Asthenia | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Erythema | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Pneumonia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Flushing | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Hypersensitivity | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any TEAE, Pertuzumab Interruption (Ptz Interrupt) | 334 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Ejection Fraction Decreased | 51 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Diarrhoea | 21 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Neutropenia | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Pneumonia | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Upper Respiratory Tract Infection | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Pyrexia | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Dyspnoea | 11 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Drug Hypersensitivity | 9 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Influenza | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Asthenia | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Neutrophil Count Decreased | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Nasopharyngitis | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Ptz Interrupt: Anaemia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any TEAE, Trastuzumab Interruption (Trz Interrupt) | 386 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Ejection Fraction Decreased | 52 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Drug Hypersensitivity | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Diarrhoea | 20 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Pyrexia | 18 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Neutropenia | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Dyspnoea | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Pneumonia | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Chills | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Infusion Related Reaction | 13 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Upper Respiratory Tract Infection | 12 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Neutrophil Count Decreased | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Influenza | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Asthenia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Vomiting | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Anaemia | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Trz Interrupt: Nasopharyngitis | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Any TEAE, Taxane Interruption (Tax Interrupt) | 354 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Neutropenia | 46 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Diarrhoea | 30 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Leukopenia | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Dyspnoea | 15 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term | Tax Interrupt: Pyrexia | 14 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Any TEAE Related to Pertuzumab (Rel to Ptz) | 1037 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Gastrointestinal Disorders | 629 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Skin and Subcutaneous Tissue Disorders | 491 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Gen. Disorders & Admin.Site Conditions | 462 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Investigations | 252 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Nervous System Disorders | 207 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Resp., Thoracic & Mediast. Disorders | 188 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Musculo. & Connective Tissue Disorders | 184 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Blood & Lymphatic System Disorders | 182 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Ptz: Infections and Infestations | 151 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Any TEAE Related to Trastuzumab (Rel to Trz) | 946 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Gastrointestinal Disorders | 435 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Gen. Disorders & Admin.Site Conditions | 434 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Skin and Subcutaneous Tissue Disorders | 384 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Investigations | 262 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Nervous System Disorders | 184 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Musculo. & Connective Tissue Disorders | 179 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Blood & Lymphatic System Disorders | 163 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Trz: Resp., Thoracic & Mediast. Disorders | 153 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Any TEAE Related to Taxane (Rel to Tax) | 1342 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Gastrointestinal Disorders | 984 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Skin and Subcutaneous Tissue Disorders | 938 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Gen. Disorders & Admin.Site Conditions | 834 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Nervous System Disorders | 764 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Blood & Lymphatic System Disorders | 457 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Musculo. & Connective Tissue Disorders | 386 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Infections and Infestations | 293 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Resp., Thoracic & Mediast. Disorders | 290 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Metabolism and Nutrition Disorders | 227 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Investigations | 201 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class | Rel to Tax: Eye Disorders | 174 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Any TEAE of Special Interest | 91 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Decline in LVEF (Category) | 90 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Ejection Fraction Decreased (PT) | 75 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Left Ventricular Dysfunction (PT) | 8 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Cardiac Failure (PT) | 7 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Cardiac Failure Congestive (PT) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Elevated ALT or AST (Category) | 1 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term | Hepatic Failure (PT) | 1 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Any TEAE to Monitor | 1320 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Infusion-/Administration-Related Reactions | 1096 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Rash/Skin Reactions | 668 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Mucositis | 618 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Cardiac Dysfunction | 478 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Neutropenia/Febrile Neutropenia | 439 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Anaphylaxis and Hypersensitivity | 124 Participants |
| Pertuzumab + Trastuzumab + Taxane | Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category | Diarrhoea Grade ≥3 | 120 Participants |
Primary
Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Trastuzumab - Grade ≥3 | 245 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Taxane - Grade ≥3 | 514 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Interruption of Pertuzumab | 334 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Interruption of Trastuzumab | 386 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Interruption of Taxane | 354 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Discontinuation of Pertuzumab | 140 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Discontinuation of Trastuzumab | 133 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Discontinuation of Taxane | 286 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE to Monitor - Any Grade | 1320 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE to Monitor - Grade ≥3 | 535 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE of Special Interest | 91 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Within 28 Days of Treatmt Discontinuation | 975 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE - Any Grade | 1419 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE - Grade 3 or Higher (≥3) | 879 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any Serious TEAE | 535 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Leading to Death | 31 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Pertuzumab - Any Grade | 1037 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Trastuzumab - Any Grade | 946 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Taxane - Any Grade | 1342 Participants |
| Pertuzumab + Trastuzumab + Taxane | Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | Any TEAE Related to Pertuzumab - Grade ≥3 | 286 Participants |
Primary
Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Serious TEAE | 415 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Leading to Death | 17 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE - Grade 3 or Higher (≥3) | 688 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Related to Pertuzumab - Any Grade | 845 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Grade ≥3 TEAE Related to Pertuzumab | 224 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE to Monitor - Any Grade | 1081 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Grade ≥3 TEAE Related to Pertuzumab | 62 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Serious TEAE | 120 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Related to Pertuzumab - Any Grade | 192 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Leading to Death | 14 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE to Monitor - Any Grade | 239 Participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE - Grade 3 or Higher (≥3) | 191 Participants |
Primary
Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment. There were 2 participants with missing evaluations for ECOG performance status at baseline who were excluded from this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 502 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 837 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 273 Participants |
| Asia | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 33 Participants |
| Asia | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 41 Participants |
| Asia | Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 13 Participants |
Primary
Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 573 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 353 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 181 Participants |
| Asia | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 179 Participants |
| Asia | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 303 Participants |
| Asia | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 103 Participants |
| North America | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 3 Participants |
| North America | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 2 Participants |
| North America | Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 3 Participants |
Primary
Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 135 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 238 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 77 Participants |
| Asia | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 400 Participants |
| Asia | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 641 Participants |
| Asia | Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 209 Participants |
Primary
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 283 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 493 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 169 Participants |
| Asia | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 252 Participants |
| Asia | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 386 Participants |
| Asia | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 117 Participants |
Primary
Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 632 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 187 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 385 Participants |
| Asia | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 109 Participants |
| Asia | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 44 Participants |
| Asia | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 74 Participants |
| North America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 5 Participants |
| North America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 9 Participants |
| North America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 22 Participants |
| South America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 37 Participants |
| South America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 63 Participants |
| South America | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 27 Participants |
| Africa | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 19 Participants |
| Africa | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 16 Participants |
| Africa | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 37 Participants |
| Other (Australia) | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 16 Participants |
| Other (Australia) | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 14 Participants |
| Other (Australia) | Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 4 Participants |
Primary
Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment. Only participants who received any taxane chemotherapy during the study were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Serious TEAE | 300 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Leading to Death | 14 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE - Grade 3 or Higher (≥3) | 491 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Related to Pertuzumab - Any Grade | 547 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Grade ≥3 TEAE Related to Pertuzumab | 171 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE to Monitor - Any Grade | 709 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE to Monitor - Any Grade | 541 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Serious TEAE | 210 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Related to Pertuzumab - Any Grade | 434 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Grade ≥3 TEAE Related to Pertuzumab | 105 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Leading to Death | 16 Participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE - Grade 3 or Higher (≥3) | 349 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Leading to Death | 1 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE - Grade 3 or Higher (≥3) | 36 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE to Monitor - Any Grade | 64 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any TEAE Related to Pertuzumab - Any Grade | 52 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Serious TEAE | 22 Participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor | Any Grade ≥3 TEAE Related to Pertuzumab | 9 Participants |
Primary
Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab
Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 353 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 610 Participants |
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 197 Participants |
| Asia | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Serious TEAE | 182 Participants |
| Asia | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any TEAE - Grade 3 or Higher (≥3) | 269 Participants |
| Asia | Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab | Any Grade ≥3 TEAE Related to Pertuzumab | 89 Participants |
Primary
Time to Onset of the First Episode of Congestive Heart Failure
Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.
Time frame: From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: Safety Population: all participants who received at least one dose of any study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Time to Onset of the First Episode of Congestive Heart Failure | NA Months |
Secondary
Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the breast cancer subscale, participants were given a series of 10 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B breast cancer subscale score, ranging from 0 to 40, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 24.98 Score on a scale | Standard Deviation 6.296 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 3 | 0.48 Score on a scale | Standard Deviation 5.101 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 6 | -0.11 Score on a scale | Standard Deviation 5.759 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 9 | 0.52 Score on a scale | Standard Deviation 5.633 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 12 | 0.89 Score on a scale | Standard Deviation 5.77 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 15 | 1.16 Score on a scale | Standard Deviation 6.18 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 18 | 1.30 Score on a scale | Standard Deviation 6.043 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 21 | 1.30 Score on a scale | Standard Deviation 5.898 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 24 | 1.39 Score on a scale | Standard Deviation 6.231 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 27 | 1.17 Score on a scale | Standard Deviation 6.043 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 30 | 1.34 Score on a scale | Standard Deviation 5.968 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 33 | 1.34 Score on a scale | Standard Deviation 6.113 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 36 | 1.33 Score on a scale | Standard Deviation 6.03 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 39 | 1.12 Score on a scale | Standard Deviation 6.21 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 42 | 1.11 Score on a scale | Standard Deviation 6.499 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 45 | 1.13 Score on a scale | Standard Deviation 6.414 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 48 | 1.00 Score on a scale | Standard Deviation 6.679 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 51 | 0.99 Score on a scale | Standard Deviation 6.43 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 54 | 0.76 Score on a scale | Standard Deviation 6.555 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 57 | 0.70 Score on a scale | Standard Deviation 6.355 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 60 | 0.80 Score on a scale | Standard Deviation 6.586 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 63 | 1.32 Score on a scale | Standard Deviation 6.96 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 66 | 0.74 Score on a scale | Standard Deviation 6.822 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 69 | 0.54 Score on a scale | Standard Deviation 6.532 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 72 | 0.50 Score on a scale | Standard Deviation 7.142 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 75 | 0.85 Score on a scale | Standard Deviation 6.925 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 78 | 1.22 Score on a scale | Standard Deviation 6.899 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 81 | 0.27 Score on a scale | Standard Deviation 7.1 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 84 | 0.55 Score on a scale | Standard Deviation 6.69 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 87 | 1.17 Score on a scale | Standard Deviation 6.882 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 90 | 0.51 Score on a scale | Standard Deviation 7.313 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 93 | 0.30 Score on a scale | Standard Deviation 7.163 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 96 | 0.65 Score on a scale | Standard Deviation 6.24 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 99 | 1.19 Score on a scale | Standard Deviation 6.957 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 102 | 0.56 Score on a scale | Standard Deviation 6.189 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 105 | 0.68 Score on a scale | Standard Deviation 6.399 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 108 | 0.19 Score on a scale | Standard Deviation 6.982 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 111 | 0.01 Score on a scale | Standard Deviation 6.814 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 114 | -1.67 Score on a scale | Standard Deviation 5.963 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 117 | -1.56 Score on a scale | Standard Deviation 5.842 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 120 | -2.17 Score on a scale | Standard Deviation 6.055 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Cycle 123 | -7.94 Score on a scale | Standard Deviation 7.307 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at End of Treatment | 0.88 Score on a scale | Standard Deviation 6.574 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | 0.66 Score on a scale | Standard Deviation 6.477 |
Secondary
Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the emotional well-being subscale, participants were given a series of 6 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B emotional well-being subscale score, ranging from 0 to 24, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 15.08 Score on a scale | Standard Deviation 4.99 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 3 | 1.69 Score on a scale | Standard Deviation 4.219 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 6 | 1.53 Score on a scale | Standard Deviation 4.526 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 9 | 1.64 Score on a scale | Standard Deviation 4.624 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 12 | 2.02 Score on a scale | Standard Deviation 4.686 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 15 | 1.98 Score on a scale | Standard Deviation 4.778 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 18 | 2.03 Score on a scale | Standard Deviation 4.861 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 21 | 2.17 Score on a scale | Standard Deviation 4.877 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 24 | 2.19 Score on a scale | Standard Deviation 5.04 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 27 | 2.21 Score on a scale | Standard Deviation 5.171 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 30 | 2.17 Score on a scale | Standard Deviation 4.763 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 33 | 2.21 Score on a scale | Standard Deviation 5.275 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 36 | 2.32 Score on a scale | Standard Deviation 5.13 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 39 | 1.99 Score on a scale | Standard Deviation 5.115 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 42 | 1.96 Score on a scale | Standard Deviation 5.451 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 45 | 2.25 Score on a scale | Standard Deviation 5.367 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 48 | 1.82 Score on a scale | Standard Deviation 5.414 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 51 | 2.32 Score on a scale | Standard Deviation 5.311 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 54 | 1.84 Score on a scale | Standard Deviation 5.325 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 57 | 1.80 Score on a scale | Standard Deviation 5.256 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 60 | 1.59 Score on a scale | Standard Deviation 5.462 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 63 | 1.70 Score on a scale | Standard Deviation 5.336 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 66 | 1.52 Score on a scale | Standard Deviation 5.074 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 69 | 1.83 Score on a scale | Standard Deviation 5.351 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 72 | 1.56 Score on a scale | Standard Deviation 5.421 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 75 | 1.58 Score on a scale | Standard Deviation 5.308 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 78 | 1.72 Score on a scale | Standard Deviation 5.463 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 81 | 2.01 Score on a scale | Standard Deviation 5.75 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 84 | 2.06 Score on a scale | Standard Deviation 5.384 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 87 | 1.97 Score on a scale | Standard Deviation 5.558 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 90 | 2.08 Score on a scale | Standard Deviation 5.686 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 93 | 2.17 Score on a scale | Standard Deviation 5.388 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 96 | 2.40 Score on a scale | Standard Deviation 5.769 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 99 | 2.30 Score on a scale | Standard Deviation 6.041 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 102 | 2.07 Score on a scale | Standard Deviation 5.949 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 105 | 2.58 Score on a scale | Standard Deviation 5.902 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 108 | 2.34 Score on a scale | Standard Deviation 6.721 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 111 | 1.19 Score on a scale | Standard Deviation 7.241 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 114 | 1.55 Score on a scale | Standard Deviation 7.944 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 117 | 1.33 Score on a scale | Standard Deviation 4.185 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 120 | 0.75 Score on a scale | Standard Deviation 2.217 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 123 | -0.50 Score on a scale | Standard Deviation 2.121 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at End of Treatment | 0.30 Score on a scale | Standard Deviation 5.001 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | 0.37 Score on a scale | Standard Deviation 5.193 |
Secondary
Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the functional well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B functional well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 16.65 Score on a scale | Standard Deviation 6.096 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 3 | -0.47 Score on a scale | Standard Deviation 4.961 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 6 | -0.79 Score on a scale | Standard Deviation 5.437 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 9 | -0.11 Score on a scale | Standard Deviation 5.572 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 12 | 0.46 Score on a scale | Standard Deviation 5.577 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 15 | 0.78 Score on a scale | Standard Deviation 5.758 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 18 | 0.83 Score on a scale | Standard Deviation 5.797 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 21 | 0.89 Score on a scale | Standard Deviation 5.804 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 24 | 0.53 Score on a scale | Standard Deviation 5.903 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 27 | 0.71 Score on a scale | Standard Deviation 6.064 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 30 | 0.60 Score on a scale | Standard Deviation 5.961 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 33 | 0.67 Score on a scale | Standard Deviation 6.209 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 36 | 0.52 Score on a scale | Standard Deviation 5.687 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 39 | 0.26 Score on a scale | Standard Deviation 5.927 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 42 | 0.31 Score on a scale | Standard Deviation 6.038 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 45 | 0.34 Score on a scale | Standard Deviation 6.049 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 48 | 0.28 Score on a scale | Standard Deviation 6.227 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 51 | 0.23 Score on a scale | Standard Deviation 5.931 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 54 | -0.06 Score on a scale | Standard Deviation 6.09 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 57 | 0.21 Score on a scale | Standard Deviation 5.925 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 60 | 0.01 Score on a scale | Standard Deviation 6.1 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 63 | -0.06 Score on a scale | Standard Deviation 6.178 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 66 | -0.07 Score on a scale | Standard Deviation 6.264 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 69 | -0.47 Score on a scale | Standard Deviation 6.476 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 72 | -0.50 Score on a scale | Standard Deviation 6.378 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 75 | -0.40 Score on a scale | Standard Deviation 6.391 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 78 | -0.18 Score on a scale | Standard Deviation 6.197 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 81 | -0.29 Score on a scale | Standard Deviation 6.046 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 84 | -0.48 Score on a scale | Standard Deviation 6.022 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 87 | -0.08 Score on a scale | Standard Deviation 6.25 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 90 | 0.16 Score on a scale | Standard Deviation 6.587 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 93 | 0.58 Score on a scale | Standard Deviation 6.161 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 96 | 1.27 Score on a scale | Standard Deviation 6.663 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 99 | 0.46 Score on a scale | Standard Deviation 6.651 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 102 | 0.96 Score on a scale | Standard Deviation 6.327 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 105 | 1.14 Score on a scale | Standard Deviation 5.922 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 108 | 1.42 Score on a scale | Standard Deviation 6.902 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 111 | 0.32 Score on a scale | Standard Deviation 6.507 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 114 | -0.25 Score on a scale | Standard Deviation 6.439 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 117 | -0.58 Score on a scale | Standard Deviation 5.316 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 120 | -2.00 Score on a scale | Standard Deviation 3.916 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 123 | -5.00 Score on a scale | Standard Deviation 2.828 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at End of Treatment | -0.50 Score on a scale | Standard Deviation 6.132 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | -0.70 Score on a scale | Standard Deviation 6.558 |
Secondary
Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the physical well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B physical well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 20.98 Score on a scale | Standard Deviation 6.044 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 3 | -1.13 Score on a scale | Standard Deviation 5.557 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 6 | -1.61 Score on a scale | Standard Deviation 5.994 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 9 | -0.31 Score on a scale | Standard Deviation 5.604 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 12 | 0.51 Score on a scale | Standard Deviation 5.599 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 15 | 0.51 Score on a scale | Standard Deviation 5.652 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 18 | 0.69 Score on a scale | Standard Deviation 5.543 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 21 | 0.73 Score on a scale | Standard Deviation 5.616 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 24 | 0.61 Score on a scale | Standard Deviation 5.69 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 27 | 0.47 Score on a scale | Standard Deviation 5.761 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 30 | 0.71 Score on a scale | Standard Deviation 5.584 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 33 | 0.56 Score on a scale | Standard Deviation 5.894 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 36 | 0.39 Score on a scale | Standard Deviation 5.512 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 39 | -0.04 Score on a scale | Standard Deviation 5.647 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 42 | 0.22 Score on a scale | Standard Deviation 5.604 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 45 | 0.09 Score on a scale | Standard Deviation 5.698 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 48 | 0.11 Score on a scale | Standard Deviation 5.564 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 51 | 0.22 Score on a scale | Standard Deviation 5.28 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 54 | -0.26 Score on a scale | Standard Deviation 5.765 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 57 | -0.35 Score on a scale | Standard Deviation 5.695 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 60 | -0.10 Score on a scale | Standard Deviation 5.63 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 63 | -0.20 Score on a scale | Standard Deviation 5.696 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 66 | 0.29 Score on a scale | Standard Deviation 5.338 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 69 | -0.60 Score on a scale | Standard Deviation 5.579 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 72 | -0.35 Score on a scale | Standard Deviation 5.494 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 75 | -0.72 Score on a scale | Standard Deviation 5.507 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 78 | -0.44 Score on a scale | Standard Deviation 5.379 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 81 | -0.65 Score on a scale | Standard Deviation 5.029 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 84 | -0.81 Score on a scale | Standard Deviation 5.249 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 87 | -0.36 Score on a scale | Standard Deviation 5.391 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 90 | -0.66 Score on a scale | Standard Deviation 5.332 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 93 | -0.42 Score on a scale | Standard Deviation 5.788 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 96 | -0.28 Score on a scale | Standard Deviation 5.178 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 99 | -0.21 Score on a scale | Standard Deviation 5.474 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 102 | -0.80 Score on a scale | Standard Deviation 5.269 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 105 | -0.07 Score on a scale | Standard Deviation 5.133 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 108 | 0.07 Score on a scale | Standard Deviation 5.775 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 111 | 0.38 Score on a scale | Standard Deviation 5.309 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 114 | -1.70 Score on a scale | Standard Deviation 4.95 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 117 | -1.83 Score on a scale | Standard Deviation 3.474 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 120 | -2.38 Score on a scale | Standard Deviation 3.092 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 123 | -5.58 Score on a scale | Standard Deviation 2.946 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at End of Treatment | -0.73 Score on a scale | Standard Deviation 6.366 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | -0.95 Score on a scale | Standard Deviation 6.393 |
Secondary
Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the social well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B social well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 22.24 Score on a scale | Standard Deviation 4.993 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 3 | -0.41 Score on a scale | Standard Deviation 4.145 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 6 | -1.09 Score on a scale | Standard Deviation 4.32 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 9 | -1.02 Score on a scale | Standard Deviation 4.728 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 12 | -1.19 Score on a scale | Standard Deviation 4.846 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 15 | -1.28 Score on a scale | Standard Deviation 4.949 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 18 | -1.19 Score on a scale | Standard Deviation 4.986 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 21 | -1.24 Score on a scale | Standard Deviation 4.881 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 24 | -1.26 Score on a scale | Standard Deviation 4.856 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 27 | -1.48 Score on a scale | Standard Deviation 4.994 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 30 | -1.18 Score on a scale | Standard Deviation 5.107 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 33 | -1.45 Score on a scale | Standard Deviation 4.852 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 36 | -1.54 Score on a scale | Standard Deviation 4.953 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 39 | -1.77 Score on a scale | Standard Deviation 5.066 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 42 | -1.73 Score on a scale | Standard Deviation 5.154 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 45 | -1.50 Score on a scale | Standard Deviation 5.238 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 48 | -1.84 Score on a scale | Standard Deviation 5.475 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 51 | -2.01 Score on a scale | Standard Deviation 5.657 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 54 | -1.77 Score on a scale | Standard Deviation 5.236 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 57 | -1.88 Score on a scale | Standard Deviation 5.117 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 60 | -2.01 Score on a scale | Standard Deviation 5.528 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 63 | -2.18 Score on a scale | Standard Deviation 5.278 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 66 | -2.19 Score on a scale | Standard Deviation 5.586 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 69 | -2.24 Score on a scale | Standard Deviation 5.434 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 72 | -2.49 Score on a scale | Standard Deviation 5.846 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 75 | -2.40 Score on a scale | Standard Deviation 5.777 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 78 | -2.33 Score on a scale | Standard Deviation 5.676 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 81 | -2.53 Score on a scale | Standard Deviation 5.609 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 84 | -2.96 Score on a scale | Standard Deviation 5.624 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 87 | -2.29 Score on a scale | Standard Deviation 5.487 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 90 | -2.38 Score on a scale | Standard Deviation 5.355 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 93 | -1.97 Score on a scale | Standard Deviation 5.102 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 96 | -1.94 Score on a scale | Standard Deviation 4.831 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 99 | -2.07 Score on a scale | Standard Deviation 5.316 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 102 | -1.70 Score on a scale | Standard Deviation 4.258 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 105 | -1.76 Score on a scale | Standard Deviation 4.074 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 108 | -1.75 Score on a scale | Standard Deviation 3.387 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 111 | -1.94 Score on a scale | Standard Deviation 3.663 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 114 | -2.31 Score on a scale | Standard Deviation 3.386 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 117 | -1.83 Score on a scale | Standard Deviation 3.6 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 120 | -2.85 Score on a scale | Standard Deviation 5.485 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Cycle 123 | -1.92 Score on a scale | Standard Deviation 2.946 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at End of Treatment | -1.29 Score on a scale | Standard Deviation 4.911 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | -1.61 Score on a scale | Standard Deviation 5.08 |
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study
The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. Participants were given a series of statements in each subscale and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B total score, ranging from 0 to 148, was the sum of the scores for each subscale, provided that at least 80% of the items had been answered; a higher score indicated a better quality of life. If any of the 5 subscale scores were missing, the total score was also set to missing. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.
Time frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Population: ITT Population: only enrolled female participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Baseline (BL): Absolute Value at Visit | 99.87 Score on a scale | Standard Deviation 20.548 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 3 | 0.40 Score on a scale | Standard Deviation 15.526 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 6 | -1.93 Score on a scale | Standard Deviation 17.611 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 9 | 0.87 Score on a scale | Standard Deviation 17.211 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 12 | 3.03 Score on a scale | Standard Deviation 17.426 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 15 | 3.33 Score on a scale | Standard Deviation 18.764 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 18 | 3.80 Score on a scale | Standard Deviation 18.689 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 21 | 4.06 Score on a scale | Standard Deviation 18.175 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 24 | 3.59 Score on a scale | Standard Deviation 19.57 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 27 | 3.14 Score on a scale | Standard Deviation 20.311 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 30 | 3.75 Score on a scale | Standard Deviation 18.877 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 33 | 3.58 Score on a scale | Standard Deviation 20.586 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 36 | 3.16 Score on a scale | Standard Deviation 18.838 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 39 | 1.66 Score on a scale | Standard Deviation 19.791 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 42 | 2.08 Score on a scale | Standard Deviation 20.658 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 45 | 2.22 Score on a scale | Standard Deviation 20.811 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 48 | 1.51 Score on a scale | Standard Deviation 21.268 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 51 | 1.95 Score on a scale | Standard Deviation 20.221 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 54 | 0.52 Score on a scale | Standard Deviation 20.784 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 57 | 0.54 Score on a scale | Standard Deviation 20.014 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 60 | 0.20 Score on a scale | Standard Deviation 21.207 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 63 | 0.61 Score on a scale | Standard Deviation 21.475 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 66 | 0.44 Score on a scale | Standard Deviation 20.633 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 69 | -0.75 Score on a scale | Standard Deviation 21.419 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 72 | -1.16 Score on a scale | Standard Deviation 21.951 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 75 | -1.14 Score on a scale | Standard Deviation 21.132 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 78 | 0.11 Score on a scale | Standard Deviation 20.807 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 81 | -1.03 Score on a scale | Standard Deviation 20.526 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 84 | -1.67 Score on a scale | Standard Deviation 21.03 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 87 | 0.62 Score on a scale | Standard Deviation 21.183 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 90 | 0.00 Score on a scale | Standard Deviation 22.289 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 93 | 0.99 Score on a scale | Standard Deviation 21.474 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 96 | 2.36 Score on a scale | Standard Deviation 21.636 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 99 | 1.36 Score on a scale | Standard Deviation 23.195 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 102 | 1.20 Score on a scale | Standard Deviation 21.262 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 105 | 3.13 Score on a scale | Standard Deviation 20.385 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 108 | 2.22 Score on a scale | Standard Deviation 23.617 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 111 | -0.48 Score on a scale | Standard Deviation 22.585 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 114 | -4.42 Score on a scale | Standard Deviation 22.323 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 117 | -4.96 Score on a scale | Standard Deviation 16.232 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 120 | -8.64 Score on a scale | Standard Deviation 13.187 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Cycle 123 | -20.94 Score on a scale | Standard Deviation 2.357 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at End of Treatment | -1.06 Score on a scale | Standard Deviation 19.923 |
| Pertuzumab + Trastuzumab + Taxane | Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study | Change from BL at Day 28 of Follow-Up | -1.96 Score on a scale | Standard Deviation 21.201 |
Secondary
Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1
The clinical benefit rate was defined as the percentage of participants whose best confirmed response (≥4 weeks later) was a complete response (CR) or partial response (PR), or stable disease (SD) that lasted at least 6 months, as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Clinical benefit responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least 20% increase in sum of diameters of target lesions and absolute increase of ≥5 mm), taking as reference the smallest sum diameters while on study.
Time frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1 | 86.2 Percentage of participants |
Secondary
Duration of Response as Assessed by the Investigator Using RECIST v1.1
Duration of response (DOR) was defined as the time from when a confirmed best overall response of complete response (CR) or partial response (PR) was first documented to first documented disease progression or death from any cause (whichever occurred first). DOR was analyzed using a Kaplan-Meier approach. Participants who had not progressed or died after having had a confirmed response were censored at the date of their last tumor measurement. Response was assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline and a documented confirmed response (CR or PR) were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Duration of Response as Assessed by the Investigator Using RECIST v1.1 | 20.01 Months |
Secondary
Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Time frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 79.5 Percentage of participants |
Secondary
Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Overall Survival | 65.31 Months |
Secondary
Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1
Best overall response (BOR) was defined as the best response recorded from the first dose of study treatment until disease progression/recurrence or death in the absence of disease progression. The hierarchy used to determine BOR: Complete Response (CR)\>Partial Response (PR)\>Stable Disease (SD)\>Progressive Disease (PD)\>Not Evaluable. Note that CR or PR was confirmed ≥4 weeks later. RECIST v1.1 responses are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.; PD = At least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study, and absolute increase of ≥5 mm.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Complete Response (Confirmed) | 14.6 Percentage of participants |
| Pertuzumab + Trastuzumab + Taxane | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Partial Response (Confirmed) | 64.9 Percentage of participants |
| Pertuzumab + Trastuzumab + Taxane | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Stable Disease | 15.3 Percentage of participants |
| Pertuzumab + Trastuzumab + Taxane | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Progressive Disease | 4.2 Percentage of participants |
| Pertuzumab + Trastuzumab + Taxane | Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 | Not Evaluable | 1.1 Percentage of participants |
Secondary
Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | 20.67 Months |
Secondary
Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Time frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 81.7 Percentage of participants |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 70.0 Percentage of participants |
Secondary
Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Survival | 70.01 Months |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Survival | 50.10 Months |
Secondary
Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 21.98 Months |
| Asia | Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 14.72 Months |
Secondary
Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study. There were 2 participants with missing evaluations for ECOG performance status at baseline who were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival | 67.25 Months |
| Asia | Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival | 31.15 Months |
Secondary
Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study. There were 2 participants with missing evaluations for ECOG performance status at baseline who were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 21.49 Months |
| Asia | Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 12.88 Months |
Secondary
Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival | 66.66 Months |
| Asia | Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival | 60.19 Months |
| North America | Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival | NA Months |
Secondary
Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 20.60 Months |
| Asia | Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 20.73 Months |
| North America | Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 32.13 Months |
Secondary
Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival | 54.08 Months |
| Asia | Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival | 73.50 Months |
Secondary
Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 15.38 Months |
| Asia | Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 23.39 Months |
Secondary
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival | 57.10 Months |
| Asia | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival | 79.80 Months |
Secondary
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 19.12 Months |
| Asia | Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 23.49 Months |
Secondary
Subgroup Analysis by Region of Enrollment: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Region of Enrollment: Overall Survival | 66.56 Months |
| Asia | Subgroup Analysis by Region of Enrollment: Overall Survival | 63.57 Months |
| North America | Subgroup Analysis by Region of Enrollment: Overall Survival | 55.56 Months |
| South America | Subgroup Analysis by Region of Enrollment: Overall Survival | NA Months |
| Africa | Subgroup Analysis by Region of Enrollment: Overall Survival | 53.22 Months |
| Other (Australia) | Subgroup Analysis by Region of Enrollment: Overall Survival | NA Months |
Secondary
Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 19.38 Months |
| Asia | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 23.79 Months |
| North America | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 25.17 Months |
| South America | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 22.37 Months |
| Africa | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 22.83 Months |
| Other (Australia) | Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | NA Months |
Secondary
Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1
The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.
Time frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline and those who had received any taxane chemotherapy were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 78.4 Percentage of participants |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 82.1 Percentage of participants |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 | 77.4 Percentage of participants |
Secondary
Subgroup Analysis by Taxane Chemotherapy: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study. Only participants who received any taxane chemotherapy during the study were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Overall Survival | 66.53 Months |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Overall Survival | 64.03 Months |
| North America | Subgroup Analysis by Taxane Chemotherapy: Overall Survival | 70.87 Months |
Secondary
Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study. Only participants who received any taxane chemotherapy during the study were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 19.38 Months |
| Asia | Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 23.23 Months |
| North America | Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 19.22 Months |
Secondary
Subgroup Analysis by Visceral Disease at Baseline: Overall Survival
Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.
Time frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Visceral Disease at Baseline: Overall Survival | 57.10 Months |
| Asia | Subgroup Analysis by Visceral Disease at Baseline: Overall Survival | 81.08 Months |
Secondary
Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1
Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.
Time frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: ITT Population: all participants enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 18.23 Months |
| Asia | Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 | 27.24 Months |
Secondary
Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1
Time to response (TTR) was defined as the time from the first study treatment administration to the date of first confirmed response (CR or PR). TTR was analyzed using a Kaplan-Meier approach. Participants who did not have CR or PR were censored at the date of their last evaluable tumor assessment. Participants for whom no post-baseline tumor assessments were available were censored at Day 1. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Population: Only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pertuzumab + Trastuzumab + Taxane | Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1 | 2.464 Months |