Trial Outcomes & Findings for A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (NCT NCT01358877)

NCT ID: NCT01358877

Last Updated: 2025-11-28

Results Overview

Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4804 participants
• Primary outcome timeframe: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
• Results posted on: 2025-11-28

Participant Flow

Overall, 4804 patients were randomized in the study, 2400 in the Pertuzumab arm and 2404 in the Placebo arm.

A total of 6263 patients were screened for the study. The most common cause of screen failure was lack of confirmation of HER2-positivity by the central laboratory which accounted for approximately half of the screen failures.

Participant milestones

Measure	Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).
Overall Study STARTED	2400	2404
Overall Study Received at Least 1 Dose of Pertuzumab	2340	24
Overall Study Received Any Study Treatment Except for Pertuzumab	38	2367
Overall Study Entered Follow-Up	2369	2381
Overall Study COMPLETED	1361	1316
Overall Study NOT COMPLETED	1039	1088

Reasons for withdrawal

Measure	Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).
Overall Study Withdrawal by Subject	475	466
Overall Study Recurrence of disease	181	269
Overall Study Lost to Follow-up	181	176
Overall Study Death	41	46
Overall Study Adverse Event	39	42
Overall Study Physician Decision	43	32
Overall Study Contralateral breast cancer	42	28
Overall Study Reason not specified	37	29

Baseline Characteristics

ITT population

Baseline characteristics by cohort

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).	Total n=4804 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 10.9 • n=30 Participants	51.4 years STANDARD_DEVIATION 10.7 • n=30 Participants	51.5 years STANDARD_DEVIATION 10.8 • n=60 Participants
Sex: Female, Male Female	2397 Participants n=30 Participants • ITT population	2396 Participants n=30 Participants • ITT population	4793 Participants n=60 Participants • ITT population
Sex: Female, Male Male	3 Participants n=30 Participants • ITT population	8 Participants n=30 Participants • ITT population	11 Participants n=60 Participants • ITT population
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=30 Participants	42 Participants n=30 Participants	87 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	432 Participants n=30 Participants	386 Participants n=30 Participants	818 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1923 Participants n=30 Participants	1976 Participants n=30 Participants	3899 Participants n=60 Participants
Race/Ethnicity, Customized White	1705 Participants n=30 Participants	1694 Participants n=30 Participants	3399 Participants n=60 Participants
Race/Ethnicity, Customized Black	32 Participants n=30 Participants	41 Participants n=30 Participants	73 Participants n=60 Participants
Race/Ethnicity, Customized Asian	590 Participants n=30 Participants	598 Participants n=30 Participants	1188 Participants n=60 Participants
Race/Ethnicity, Customized Other	66 Participants n=30 Participants	69 Participants n=30 Participants	135 Participants n=60 Participants
Race/Ethnicity, Customized Not reported	7 Participants n=30 Participants	2 Participants n=30 Participants	9 Participants n=60 Participants
Nodal Status 0 Positive Nodes and Tumor ≤1 cm	90 Participants n=30 Participants	84 Participants n=30 Participants	174 Participants n=60 Participants
Nodal Status 0 Positive Nodes and Tumor >1 cm	807 Participants n=30 Participants	818 Participants n=30 Participants	1625 Participants n=60 Participants
Nodal Status 1 to 3 Positive Nodes	907 Participants n=30 Participants	900 Participants n=30 Participants	1807 Participants n=60 Participants
Nodal Status ≥4 Positive Nodes	596 Participants n=30 Participants	602 Participants n=30 Participants	1198 Participants n=60 Participants
Adjuvant Chemotherapy Regimen Anthracycline containing regimen	1865 Participants n=30 Participants	1877 Participants n=30 Participants	3742 Participants n=60 Participants
Adjuvant Chemotherapy Regimen Non-anthracycline containing regimen	535 Participants n=30 Participants	527 Participants n=30 Participants	1062 Participants n=60 Participants
Hormone Receptor Status Negative (ER and PgR negative)	864 Participants n=30 Participants	858 Participants n=30 Participants	1722 Participants n=60 Participants
Hormone Receptor Status Positive (ER and/or PgR positive)	1536 Participants n=30 Participants	1546 Participants n=30 Participants	3082 Participants n=60 Participants
Protocol Version at Enrollment Protocol Version A	1828 Participants n=30 Participants	1827 Participants n=30 Participants	3655 Participants n=60 Participants
Protocol Version at Enrollment Protocol Version B	572 Participants n=30 Participants	577 Participants n=30 Participants	1149 Participants n=60 Participants

PRIMARY outcome

Timeframe: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	7.1 percentage of participants	8.7 percentage of participants

PRIMARY outcome

Timeframe: 3 years

Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (excluding SPNBC) at 3 years.

Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2101 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2108 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	94.06 Estimate of percentage of participants Interval 93.09 to 95.03	93.24 Estimate of percentage of participants Interval 92.21 to 94.26

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.

The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 6 Years	90.56 Estimate of percentage of participants Interval 89.35 to 91.77	87.76 Estimate of percentage of participants Interval 86.4 to 89.13
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 8 Years	88.43 Estimate of percentage of participants Interval 87.1 to 89.76	85.76 Estimate of percentage of participants Interval 84.32 to 87.21
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 10 Years	87.17 Estimate of percentage of participants Interval 85.77 to 88.57	83.82 Estimate of percentage of participants Interval 82.29 to 85.36

SECONDARY outcome

Timeframe: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	7.9 percentage of participants	9.6 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years.

Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2093 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2095 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	93.50 Estimate of percentage of participants Interval 92.49 to 94.51	92.51 Estimate of percentage of participants Interval 91.43 to 93.58

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.

Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 6 Years	89.31 Estimate of percentage of participants Interval 88.03 to 90.59	86.42 Estimate of percentage of participants Interval 85.0 to 87.44
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 8 Years	87.08 Estimate of percentage of participants Interval 85.69 to 88.48	83.82 Estimate of percentage of participants Interval 82.29 to 85.34
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 10 Years	85.23 Estimate of percentage of participants Interval 83.74 to 86.71	81.31 Estimate of percentage of participants Interval 79.69 to 82.93

SECONDARY outcome

Timeframe: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	8.0 percentage of participants	9.8 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years.

Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2091 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2090 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	93.42 Estimate of percentage of participants Interval 92.4 to 94.43	92.29 Estimate of percentage of participants Interval 91.21 to 93.38

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.

Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 6 Years	88.99 Estimate of percentage of participants Interval 87.69 to 90.29	86.03 Estimate of percentage of participants Interval 84.59 to 87.47
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 8 Years	86.92 Estimate of percentage of participants Interval 85.52 to 88.32	83.19 Estimate of percentage of participants Interval 81.64 to 88.74
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 10 Years	85.01 Estimate of percentage of participants Interval 83.52 to 86.5	80.54 Estimate of percentage of participants Interval 78.89 to 82.19

SECONDARY outcome

Timeframe: Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants who died due to any cause is reported.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants Who Died, First Interim Overall Survival Analysis	3.3 percentage of participants	3.7 percentage of participants

SECONDARY outcome

Timeframe: Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)

Population: ITT population

Percentage of participants who died due to any cause is reported.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants Who Died, Final Overall Survival Analysis	8.54 percentage of participants	10.27 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for death at Year 3.

The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2186 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2209 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years	97.65 Estimate of percentage of participants Interval 97.03 to 98.27	97.67 Estimate of percentage of participants Interval 97.06 to 98.29

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for death at at the time of analysis for each timepoint.

The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years 10 Years	91.55 Estimate of percentage of participants Interval 90.38 to 92.71	89.79 Estimate of percentage of participants Interval 88.53 to 91.06
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years 6 Years	94.78 Estimate of percentage of participants Interval 93.85 to 95.71	93.93 Estimate of percentage of participants Interval 92.93 to 94.92
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years 8 Years	92.74 Estimate of percentage of participants Interval 91.66 to 93.82	91.96 Estimate of percentage of participants Interval 90.83 to 93.09

SECONDARY outcome

Timeframe: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	5.8 percentage of participants	7.2 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at 3 years.

Kaplan-Meier estimate of the percentage of participants who were RFI event-free at 3 years is reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2116 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2129 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	95.18 Estimate of percentage of participants Interval 94.3 to 96.06	94.27 Estimate of percentage of participants Interval 93.32 to 95.21

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint.

Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 6 Years	92.49 Estimate of percentage of participants Interval 91.4 to 93.59	89.91 Estimate of percentage of participants Interval 88.66 to 91.16
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 8 Years	92.11 Estimate of percentage of participants Interval 90.99 to 93.23	88.88 Estimate of percentage of participants Interval 87.59 to 90.18
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 10 Years	91.87 Estimate of percentage of participants Interval 90.74 to 93.0	88.10 Estimate of percentage of participants Interval 86.76 to 89.44

SECONDARY outcome

Timeframe: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

Population: ITT population

Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	5.0 percentage of participants	6.0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DRFI event at 3 years.

Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at 3 years is reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2126 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2145 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings	95.70 Estimate of percentage of participants Interval 94.86 to 96.53	95.13 Estimate of percentage of participants Interval 94.25 to 96.0

SECONDARY outcome

Timeframe: 6, 8, and 10 years

Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint.

Kaplan-Meier estimates of the percentage of participants who were DRFI event-free at 6, 8, and 10 years are reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 6 Years	93.37 Estimate of percentage of participants Interval 92.34 to 94.4	91.57 Estimate of percentage of participants Interval 90.42 to 92.72
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 8 Years	92.94 Estimate of percentage of participants Interval 91.88 to 94.01	90.69 Estimate of percentage of participants Interval 89.49 to 91.89
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings 10 Years	92.85 Estimate of percentage of participants Interval 91.78 to 93.92	90.01 Estimate of percentage of participants Interval 88.77 to 91.25

SECONDARY outcome

Timeframe: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)

Population: Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.

Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Primary Cardiac Event, Primary Analysis Heart Failure and LVEF Decline	0.6 percentage of participants	0.2 percentage of participants
Percentage of Participants With Primary Cardiac Event, Primary Analysis Primary Cardiac Event (Composite)	0.7 percentage of participants	0.3 percentage of participants
Percentage of Participants With Primary Cardiac Event, Primary Analysis Cardiac Death (Definite or Probable)	0.1 percentage of participants	0.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)

Population: Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.

Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Primary Cardiac Event, Final Analysis Primary Cardiac Event (Composite)	0.9 percentage of participants	0.5 percentage of participants
Percentage of Participants With Primary Cardiac Event, Final Analysis Heart Failure and LVEF Decline	0.8 percentage of participants	0.3 percentage of participants
Percentage of Participants With Primary Cardiac Event, Final Analysis Cardiac Death (Definite or Probable)	0.1 percentage of participants	0.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)

Population: Safety population

Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Secondary Cardiac Event, Primary Analysis	2.7 percentage of participants	2.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)

Population: Safety population

Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Secondary Cardiac Event, Final Analysis	2.9 percentage of participants	3.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)

Population: Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of participants evaluable for this outcome measure at specified timepoint.

LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2363 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2401 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis Baseline	65.2 percentage of blood pumped out Standard Deviation 5.9	65.3 percentage of blood pumped out Standard Deviation 6.1
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis Change to Worst Value	-7.5 percentage of blood pumped out Standard Deviation 6.6	-7.6 percentage of blood pumped out Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)

Population: Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of participants evaluable for this outcome measure at specified timepoint.

LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2363 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2401 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis Baseline	65.2 percentage of blood pumped out Standard Deviation 5.9	65.3 percentage of blood pumped out Standard Deviation 6.1
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis Change to Worst Value	-8.6 percentage of blood pumped out Standard Deviation 6.8	-8.6 percentage of blood pumped out Standard Deviation 7.0

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2329 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2338 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Baseline	72.9 units on a scale Standard Deviation 19.7	72.5 units on a scale Standard Deviation 19.7
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at Week 13	-11.2 units on a scale Standard Deviation 22.8	-10.2 units on a scale Standard Deviation 22.6
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at Week 25	-4.4 units on a scale Standard Deviation 21.6	-2.9 units on a scale Standard Deviation 21.0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at EOT	-3.1 units on a scale Standard Deviation 21.9	-1.1 units on a scale Standard Deviation 21.8
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at FU Month 18	1.9 units on a scale Standard Deviation 21.5	1.3 units on a scale Standard Deviation 22.2
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at FU Month 24	2.2 units on a scale Standard Deviation 22.1	2.4 units on a scale Standard Deviation 22.1
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Change at FU Month 36	2.8 units on a scale Standard Deviation 21.4	1.8 units on a scale Standard Deviation 22.5

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2338 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2342 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Baseline: Physical	89.6 units on a scale Standard Deviation 12.9	89.1 units on a scale Standard Deviation 13.4
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 13: Physical	-10.7 units on a scale Standard Deviation 17.2	-10.6 units on a scale Standard Deviation 17.7
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 25: Physical	-4.6 units on a scale Standard Deviation 14.5	-4.3 units on a scale Standard Deviation 14.5
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at EOT: Physical	-4.1 units on a scale Standard Deviation 14.7	-3.2 units on a scale Standard Deviation 14.9
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 18: Physical	-0.9 units on a scale Standard Deviation 13.5	-0.9 units on a scale Standard Deviation 14.5
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 24: Physical	-0.4 units on a scale Standard Deviation 13.8	-0.3 units on a scale Standard Deviation 14.5
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 36: Physical	-0.3 units on a scale Standard Deviation 14.1	-0.1 units on a scale Standard Deviation 13.9
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Baseline: Role	79.8 units on a scale Standard Deviation 24.7	79.4 units on a scale Standard Deviation 25.2
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 13: Role	-8.0 units on a scale Standard Deviation 28.6	-8.5 units on a scale Standard Deviation 29.5
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 25: Role	-0.7 units on a scale Standard Deviation 26.4	0.4 units on a scale Standard Deviation 27.8
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at EOT: Role	0.4 units on a scale Standard Deviation 27.8	2.3 units on a scale Standard Deviation 28.1
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 18: Role	6.1 units on a scale Standard Deviation 26.5	5.7 units on a scale Standard Deviation 28.9
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 24: Role	7.3 units on a scale Standard Deviation 26.8	6.9 units on a scale Standard Deviation 28.2
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 36: Role	7.9 units on a scale Standard Deviation 26.4	7.6 units on a scale Standard Deviation 27.9
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Baseline: Social	81.9 units on a scale Standard Deviation 22.9	80.6 units on a scale Standard Deviation 24.1
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 13: Social	-8.7 units on a scale Standard Deviation 25.8	-7.8 units on a scale Standard Deviation 27.1
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 25: Social	-2.2 units on a scale Standard Deviation 24.5	-0.7 units on a scale Standard Deviation 26.3
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at EOT: Social	0.0 units on a scale Standard Deviation 25.2	1.2 units on a scale Standard Deviation 26.3
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 18: Social	5.0 units on a scale Standard Deviation 23.8	4.8 units on a scale Standard Deviation 26.7
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 24: Social	5.5 units on a scale Standard Deviation 24.8	6.5 units on a scale Standard Deviation 26.6
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 36: Social	6.6 units on a scale Standard Deviation 24.9	7.1 units on a scale Standard Deviation 27.3
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Baseline: Cognitive	88.8 units on a scale Standard Deviation 16.6	87.9 units on a scale Standard Deviation 17.9
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 13: Cognitive	-9.1 units on a scale Standard Deviation 20.5	-9.0 units on a scale Standard Deviation 21.4
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 25: Cognitive	-7.6 units on a scale Standard Deviation 20.4	-7.0 units on a scale Standard Deviation 20.8
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at EOT: Cognitive	-7.7 units on a scale Standard Deviation 20.6	-7.2 units on a scale Standard Deviation 21.4
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 18: Cognitive	-6.1 units on a scale Standard Deviation 19.6	-5.8 units on a scale Standard Deviation 21.2
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 24: Cognitive	-6.2 units on a scale Standard Deviation 20.5	-5.5 units on a scale Standard Deviation 21.7
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 36: Cognitive	-5.4 units on a scale Standard Deviation 20.6	-4.9 units on a scale Standard Deviation 21.8
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Baseline: Emotional	72.8 units on a scale Standard Deviation 22.4	71.3 units on a scale Standard Deviation 22.7
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 13: Emotional	3.3 units on a scale Standard Deviation 22.2	2.9 units on a scale Standard Deviation 22.5
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at Week 25: Emotional	5.1 units on a scale Standard Deviation 22.7	5.9 units on a scale Standard Deviation 22.2
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at EOT: Emotional	5.6 units on a scale Standard Deviation 23.2	6.2 units on a scale Standard Deviation 23.4
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 18: Emotional	7.7 units on a scale Standard Deviation 23.4	7.6 units on a scale Standard Deviation 23.4
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 24: Emotional	7.8 units on a scale Standard Deviation 23.3	8.5 units on a scale Standard Deviation 24.2
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Change at FU Month 36: Emotional	7.8 units on a scale Standard Deviation 23.8	8.4 units on a scale Standard Deviation 24.4

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2338 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2342 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Diarrhea	5.2 units on a scale Standard Deviation 14.4	5.1 units on a scale Standard Deviation 13.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Diarrhea	22.3 units on a scale Standard Deviation 29.8	9.2 units on a scale Standard Deviation 23.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Diarrhea	13.2 units on a scale Standard Deviation 26.5	3.3 units on a scale Standard Deviation 19.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Diarrhea	12.2 units on a scale Standard Deviation 26.9	2.9 units on a scale Standard Deviation 20.0
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Diarrhea	-0.5 units on a scale Standard Deviation 17.7	0.2 units on a scale Standard Deviation 17.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Diarrhea	-0.8 units on a scale Standard Deviation 17.4	0.2 units on a scale Standard Deviation 18.3
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Diarrhea	-0.8 units on a scale Standard Deviation 16.5	0.3 units on a scale Standard Deviation 16.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Fatigue	22.4 units on a scale Standard Deviation 19.7	23.2 units on a scale Standard Deviation 20.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Fatigue	16.1 units on a scale Standard Deviation 24.3	16.2 units on a scale Standard Deviation 24.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Fatigue	7.8 units on a scale Standard Deviation 22.5	6.6 units on a scale Standard Deviation 22.3
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Fatigue	7.1 units on a scale Standard Deviation 23.0	5.2 units on a scale Standard Deviation 23.0
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Fatigue	1.1 units on a scale Standard Deviation 21.7	1.2 units on a scale Standard Deviation 22.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Fatigue	0.4 units on a scale Standard Deviation 22.0	0.4 units on a scale Standard Deviation 22.6
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Fatigue	-0.2 units on a scale Standard Deviation 21.8	0.6 units on a scale Standard Deviation 22.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Dyspnea	6.8 units on a scale Standard Deviation 15.5	8.0 units on a scale Standard Deviation 17.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Dyspnea	12.3 units on a scale Standard Deviation 23.8	14.6 units on a scale Standard Deviation 26.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Dyspnea	6.3 units on a scale Standard Deviation 19.9	6.4 units on a scale Standard Deviation 22.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Dyspnea	6.6 units on a scale Standard Deviation 20.5	6.5 units on a scale Standard Deviation 22.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Dyspnea	5.9 units on a scale Standard Deviation 21.0	5.0 units on a scale Standard Deviation 21.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Dyspnea	5.1 units on a scale Standard Deviation 20.5	5.3 units on a scale Standard Deviation 22.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Dyspnea	5.1 units on a scale Standard Deviation 20.5	5.3 units on a scale Standard Deviation 22.3
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Appetite Loss	8.5 units on a scale Standard Deviation 18.2	9.1 units on a scale Standard Deviation 18.7
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Appetite Loss	13.6 units on a scale Standard Deviation 29.2	7.7 units on a scale Standard Deviation 27.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Appetite Loss	5.2 units on a scale Standard Deviation 25.1	0.3 units on a scale Standard Deviation 22.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Appetite Loss	3.0 units on a scale Standard Deviation 24.5	-0.9 units on a scale Standard Deviation 22.6
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Appetite Loss	-3.0 units on a scale Standard Deviation 20.1	-3.1 units on a scale Standard Deviation 21.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Appetite Loss	-3.2 units on a scale Standard Deviation 20.6	-3.3 units on a scale Standard Deviation 21.0
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Appetite Loss	-3.0 units on a scale Standard Deviation 20.4	-2.7 units on a scale Standard Deviation 21.2
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Insomnia	25.3 units on a scale Standard Deviation 27.4	27.3 units on a scale Standard Deviation 28.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Insomnia	6.3 units on a scale Standard Deviation 30.3	5.1 units on a scale Standard Deviation 32.2
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Insomnia	4.3 units on a scale Standard Deviation 30.6	2.0 units on a scale Standard Deviation 31.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Insomnia	3.2 units on a scale Standard Deviation 31.0	0.9 units on a scale Standard Deviation 32.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Insomnia	-0.1 units on a scale Standard Deviation 31.1	0.4 units on a scale Standard Deviation 32.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Insomnia	-1.5 units on a scale Standard Deviation 31.3	-1.1 units on a scale Standard Deviation 32.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Insomnia	-0.3 units on a scale Standard Deviation 31.1	-0.5 units on a scale Standard Deviation 33.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: N/V	2.7 units on a scale Standard Deviation 8.2	3.1 units on a scale Standard Deviation 9.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: N/V	5.6 units on a scale Standard Deviation 15.7	3.7 units on a scale Standard Deviation 14.5
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: N/V	1.1 units on a scale Standard Deviation 11.8	0.5 units on a scale Standard Deviation 12.4
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: N/V	1.6 units on a scale Standard Deviation 12.7	0.8 units on a scale Standard Deviation 13.2
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: N/V	-0.2 units on a scale Standard Deviation 10.5	-0.4 units on a scale Standard Deviation 12.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: N/V	0.0 units on a scale Standard Deviation 10.7	-0.1 units on a scale Standard Deviation 11.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: N/V	0.3 units on a scale Standard Deviation 11.0	0.2 units on a scale Standard Deviation 11.7
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Constipation	8.7 units on a scale Standard Deviation 19.1	10.0 units on a scale Standard Deviation 19.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Constipation	1.4 units on a scale Standard Deviation 23.5	4.1 units on a scale Standard Deviation 25.6
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Constipation	-0.7 units on a scale Standard Deviation 21.8	0.2 units on a scale Standard Deviation 22.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Constipation	0.1 units on a scale Standard Deviation 22.4	0.9 units on a scale Standard Deviation 23.3
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Constipation	3.0 units on a scale Standard Deviation 23.3	1.5 units on a scale Standard Deviation 23.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Constipation	2.1 units on a scale Standard Deviation 23.1	0.6 units on a scale Standard Deviation 22.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Constipation	2.1 units on a scale Standard Deviation 22.9	1.5 units on a scale Standard Deviation 22.7
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Baseline: Pain	18.8 units on a scale Standard Deviation 21.4	19.6 units on a scale Standard Deviation 22.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 13: Pain	2.3 units on a scale Standard Deviation 25.4	5.0 units on a scale Standard Deviation 26.1
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at Week 25: Pain	1.4 units on a scale Standard Deviation 24.1	1.4 units on a scale Standard Deviation 24.9
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at EOT: Pain	0.1 units on a scale Standard Deviation 24.7	0.5 units on a scale Standard Deviation 25.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 18: Pain	-1.3 units on a scale Standard Deviation 23.3	-0.5 units on a scale Standard Deviation 25.8
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 24: Pain	-1.6 units on a scale Standard Deviation 24.2	-2.2 units on a scale Standard Deviation 25.6
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Change at FU Month 36: Pain	-2.6 units on a scale Standard Deviation 24.4	-2.3 units on a scale Standard Deviation 25.0

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2319 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2334 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Baseline	20.3 units on a scale Standard Deviation 28.7	22.1 units on a scale Standard Deviation 30.0
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at Week 13	3.1 units on a scale Standard Deviation 26.1	1.7 units on a scale Standard Deviation 27.0
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at Week 25	2.3 units on a scale Standard Deviation 26.8	-0.3 units on a scale Standard Deviation 26.9
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at EOT	-0.2 units on a scale Standard Deviation 27.6	-1.5 units on a scale Standard Deviation 27.2
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at FU Month 18	-4.1 units on a scale Standard Deviation 27.9	-5.1 units on a scale Standard Deviation 27.5
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at FU Month 24	-5.2 units on a scale Standard Deviation 28.6	-6.9 units on a scale Standard Deviation 29.3
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Change at FU Month 36	-7.1 units on a scale Standard Deviation 28.5	-8.3 units on a scale Standard Deviation 28.3

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2313 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2318 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Baseline: Body Image	79.7 units on a scale Standard Deviation 23.5	78.9 units on a scale Standard Deviation 23.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 13: Body Image	-12.9 units on a scale Standard Deviation 24.7	-13.9 units on a scale Standard Deviation 25.2
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 25: Body Image	-7.6 units on a scale Standard Deviation 23.8	-7.3 units on a scale Standard Deviation 23.4
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at EOT: Body Image	-4.9 units on a scale Standard Deviation 23.7	-6.0 units on a scale Standard Deviation 24.6
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 18: Body Image	-0.1 units on a scale Standard Deviation 23.3	-1.3 units on a scale Standard Deviation 23.3
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 24: Body Image	0.5 units on a scale Standard Deviation 23.6	0.1 units on a scale Standard Deviation 23.5
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 36: Body Image	1.7 units on a scale Standard Deviation 24.4	0.7 units on a scale Standard Deviation 24.6
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Baseline: Sexual Enjoyment	54.0 units on a scale Standard Deviation 30.8	55.0 units on a scale Standard Deviation 30.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 13: Sexual Enjoyment	-16.5 units on a scale Standard Deviation 28.4	-13.1 units on a scale Standard Deviation 27.2
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 25: Sexual Enjoyment	-11.9 units on a scale Standard Deviation 26.8	-7.9 units on a scale Standard Deviation 26.5
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at EOT: Sexual Enjoyment	-10.7 units on a scale Standard Deviation 27.5	-8.0 units on a scale Standard Deviation 27.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 18: Sexual Enjoyment	-4.2 units on a scale Standard Deviation 28.5	-6.7 units on a scale Standard Deviation 26.5
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 24: Sexual Enjoyment	-6.0 units on a scale Standard Deviation 28.4	-5.0 units on a scale Standard Deviation 27.6
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 36: Sexual Enjoyment	-5.3 units on a scale Standard Deviation 28.1	-6.0 units on a scale Standard Deviation 26.8
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Baseline: Sexual Function	19.6 units on a scale Standard Deviation 23.8	20.8 units on a scale Standard Deviation 24.3
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 13: Sexual Function	-5.6 units on a scale Standard Deviation 20.5	-6.6 units on a scale Standard Deviation 20.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 25: Sexual Function	-2.6 units on a scale Standard Deviation 20.8	-2.3 units on a scale Standard Deviation 20.9
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at EOT: Sexual Function	-1.0 units on a scale Standard Deviation 20.8	-1.4 units on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 18: Sexual Function	2.5 units on a scale Standard Deviation 22.8	1.4 units on a scale Standard Deviation 21.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 24: Sexual Function	2.8 units on a scale Standard Deviation 22.9	1.8 units on a scale Standard Deviation 22.7
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 36: Sexual Function	2.6 units on a scale Standard Deviation 24.0	1.6 units on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Baseline: FP	51.3 units on a scale Standard Deviation 31.7	50.5 units on a scale Standard Deviation 31.5
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 13: FP	3.1 units on a scale Standard Deviation 30.2	1.8 units on a scale Standard Deviation 31.9
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at Week 25: FP	6.3 units on a scale Standard Deviation 31.1	5.4 units on a scale Standard Deviation 31.2
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at EOT: FP	7.7 units on a scale Standard Deviation 32.2	6.9 units on a scale Standard Deviation 31.8
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 18: FP	12.9 units on a scale Standard Deviation 32.0	10.5 units on a scale Standard Deviation 32.0
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 24 : FP	13.7 units on a scale Standard Deviation 32.9	12.9 units on a scale Standard Deviation 32.9
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Change at FU Month 36: FP	14.7 units on a scale Standard Deviation 34.1	13.6 units on a scale Standard Deviation 32.9

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2331 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2335 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Baseline:Systemic SE	9.5 units on a scale Standard Deviation 10.9	10.2 units on a scale Standard Deviation 11.2
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 13: Systemic SE	21.1 units on a scale Standard Deviation 17.5	21.7 units on a scale Standard Deviation 17.9
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 25: Systemic SE	9.2 units on a scale Standard Deviation 14.2	8.2 units on a scale Standard Deviation 14.2
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at EOT: Systemic SE	8.3 units on a scale Standard Deviation 15.4	7.5 units on a scale Standard Deviation 14.8
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 18: Systemic SE	4.4 units on a scale Standard Deviation 12.8	5.5 units on a scale Standard Deviation 13.4
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 24: Systemic SE	4.1 units on a scale Standard Deviation 13.2	4.9 units on a scale Standard Deviation 13.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 36: Systemic SE	4.5 units on a scale Standard Deviation 13.6	5.2 units on a scale Standard Deviation 13.8
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Baseline: Hair Loss	26.4 units on a scale Standard Deviation 32.8	22.1 units on a scale Standard Deviation 29.0
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 13: Hair Loss	17.3 units on a scale Standard Deviation 43.6	21.2 units on a scale Standard Deviation 37.8
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 25: Hair Loss	8.3 units on a scale Standard Deviation 38.0	14.5 units on a scale Standard Deviation 38.4
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at EOT: Hair Loss	10.9 units on a scale Standard Deviation 40.1	17.9 units on a scale Standard Deviation 39.8
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 18: Hair Loss	-7.0 units on a scale Standard Deviation 36.0	3.2 units on a scale Standard Deviation 34.9
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 24: Hair Loss	-4.1 units on a scale Standard Deviation 39.3	0.7 units on a scale Standard Deviation 36.0
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 36: Hair Loss	-5.6 units on a scale Standard Deviation 42.3	2.4 units on a scale Standard Deviation 34.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Baseline: Arm Symptoms	21.6 units on a scale Standard Deviation 19.1	21.7 units on a scale Standard Deviation 19.2
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 13: Arm Symptoms	-4.7 units on a scale Standard Deviation 20.8	-2.1 units on a scale Standard Deviation 21.5
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 25: Arm Symptoms	-2.9 units on a scale Standard Deviation 21.3	-2.3 units on a scale Standard Deviation 21.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at EOT: Arm Symptoms	-3.5 units on a scale Standard Deviation 21.5	-3.4 units on a scale Standard Deviation 21.4
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 18: Arm Symptoms	-4.0 units on a scale Standard Deviation 21.8	-3.9 units on a scale Standard Deviation 22.5
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 24: Arm Symptoms	-5.1 units on a scale Standard Deviation 21.6	-5.0 units on a scale Standard Deviation 22.3
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 36: Arm Symptoms	-5.9 units on a scale Standard Deviation 21.8	-4.7 units on a scale Standard Deviation 22.4
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Baseline: Breast Symptoms	19.5 units on a scale Standard Deviation 17.5	20.4 units on a scale Standard Deviation 17.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 13: Breast Symptoms	-5.0 units on a scale Standard Deviation 18.4	-5.2 units on a scale Standard Deviation 18.0
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at Week 25: Breast Symptoms	1.9 units on a scale Standard Deviation 20.7	-0.4 units on a scale Standard Deviation 20.6
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at EOT: Breast Symptoms	-0.6 units on a scale Standard Deviation 20.2	-3.8 units on a scale Standard Deviation 19.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 18: Breast Symptoms	-3.0 units on a scale Standard Deviation 18.7	-5.9 units on a scale Standard Deviation 18.8
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 24: Breast Symptoms	-6.4 units on a scale Standard Deviation 18.4	-7.3 units on a scale Standard Deviation 18.7
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Change at FU Month 36: Breast Symptoms	-7.3 units on a scale Standard Deviation 18.8	-7.9 units on a scale Standard Deviation 19.0

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Baseline: No problems	93.8 percentage of participants	92.9 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Baseline: Some problems	6.2 percentage of participants	6.9 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Baseline: Confined to bed	0.0 percentage of participants	0.2 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 13: No problems	77.5 percentage of participants	74.8 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 13: Some problems	22.1 percentage of participants	24.8 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 13: Confined to bed	0.4 percentage of participants	0.4 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 25: No problems	83.8 percentage of participants	82.7 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 25: Some problems	16.1 percentage of participants	17.2 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Week 25: Confined to bed	0.1 percentage of participants	0.1 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain EOT: No problems	85.1 percentage of participants	84.9 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain EOT: Some problems	14.8 percentage of participants	14.9 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain EOT: Confined to bed	0.1 percentage of participants	0.2 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 18: No problems	88.8 percentage of participants	87.0 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 18: Some problems	11.2 percentage of participants	12.8 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 18: Confined to bed	0.1 percentage of participants	0.2 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 24: No problems	87.8 percentage of participants	87.7 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 24: Some problems	12.1 percentage of participants	12.1 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 24: Confined to bed	0.1 percentage of participants	0.1 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 36: No problems	88.5 percentage of participants	87.8 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 36: Some problems	11.5 percentage of participants	12.1 percentage of participants
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain FU Month 36: Confined to bed	0.0 percentage of participants	0.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Baseline: Unable	0.3 percentage of participants	0.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 13: No problems	94.3 percentage of participants	93.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Baseline: No problems	89.7 percentage of participants	90.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Baseline: Some problems	10.0 percentage of participants	9.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 13: Some problems	5.3 percentage of participants	6.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 13: Unable	0.4 percentage of participants	0.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 25: No problems	95.5 percentage of participants	95.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 25: Some problems	4.3 percentage of participants	4.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Week 25: Unable	0.1 percentage of participants	0.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain EOT: No problems	95.4 percentage of participants	95.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain EOT: Some problems	4.4 percentage of participants	4.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain EOT: Unable	0.2 percentage of participants	0.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 18: No problems	97.2 percentage of participants	96.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 18: Some problems	2.6 percentage of participants	3.6 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 18: Unable	0.2 percentage of participants	0.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 24: No problems	96.9 percentage of participants	96.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 24: Some problems	2.8 percentage of participants	3.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 24: Unable	0.3 percentage of participants	0.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 36: No problems	97.3 percentage of participants	96.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 36: Some problems	2.5 percentage of participants	3.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain FU Month 36: Unable	0.2 percentage of participants	0.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 18: Some problems	20.6 percentage of participants	23.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 18: Unable	0.9 percentage of participants	0.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 24: No problems	78.7 percentage of participants	79.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 24: Some problems	20.4 percentage of participants	19.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 24: Unable	0.9 percentage of participants	1.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 36: No problems	80.9 percentage of participants	79.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 36: Some problems	18.3 percentage of participants	19.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 36: Unable	0.7 percentage of participants	0.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Baseline: No problems	67.4 percentage of participants	66.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Baseline: Some problems	30.4 percentage of participants	32.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Baseline: Unable	2.2 percentage of participants	1.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 13: No problems	56.8 percentage of participants	54.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 13: Some problems	40.1 percentage of participants	43.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 13: Unable	3.1 percentage of participants	2.9 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 25: No problems	66.5 percentage of participants	65.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 25: Some problems	32.2 percentage of participants	32.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Week 25: Unable	1.2 percentage of participants	1.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain EOT: No problems	72.4 percentage of participants	72.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain EOT: Some problems	26.3 percentage of participants	26.6 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain EOT: Unable	1.3 percentage of participants	0.9 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain FU Month 18: No problems	78.5 percentage of participants	76.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Baseline: No pain/discomfort	49.0 percentage of participants	49.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Baseline: Moderate pain/discomfort	50.0 percentage of participants	49.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Baseline: Extreme pain/discomfort	1.0 percentage of participants	1.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 13: No pain/discomfort	44.6 percentage of participants	40.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 13: Moderate pain/discomfort	52.7 percentage of participants	56.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 13: Extreme pain/discomfort	2.7 percentage of participants	3.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 25: No pain/discomfort	44.3 percentage of participants	43.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 25: Moderate pain/discomfort	53.3 percentage of participants	54.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Week 25: Extreme pain/discomfort	2.4 percentage of participants	1.9 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain EOT: No pain/discomfort	49.3 percentage of participants	50.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain EOT: Moderate pain/discomfort	48.5 percentage of participants	47.6 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain EOT: Extreme pain/discomfort	2.2 percentage of participants	2.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 18: No pain/discomfort	51.3 percentage of participants	53.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 18: Moderate pain/discomfort	46.6 percentage of participants	44.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 18: Extreme pain/discomfort	2.1 percentage of participants	2.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 24: No pain/discomfort	56.7 percentage of participants	56.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 24: Moderate pain/discomfort	41.3 percentage of participants	41.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 24: Extreme pain/discomfort	1.9 percentage of participants	2.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 36: No pain/discomfort	59.5 percentage of participants	57.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 36: Moderate pain/discomfort	38.9 percentage of participants	40.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain FU Month 36: Extreme pain/discomfort	1.6 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36

Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2400 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2404 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Baseline: Not anxious/depress	47.1 percentage of participants	44.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Baseline: Moderate anxious/depress	49.4 percentage of participants	50.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Baseline: Extreme anxious/depress	3.5 percentage of participants	5.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 13: Not anxious/depress	53.6 percentage of participants	52.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 13: Moderate anxious/depress	43.4 percentage of participants	44.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 13: Extreme anxious/depress	3.0 percentage of participants	3.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 25: No anxious/depress	55.5 percentage of participants	55.5 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 25: Moderate anxious/depress	41.9 percentage of participants	41.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Week 25: Extreme anxious/depress	2.5 percentage of participants	2.7 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain EOT: Not anxious/depress	58.5 percentage of participants	58.3 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain EOT: Moderate anxious/depress	38.9 percentage of participants	39.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain EOT: Extreme anxious/depress	2.6 percentage of participants	2.6 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 18: Not anxious/depress	61.4 percentage of participants	59.9 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 18: Moderate anxious/depress	36.2 percentage of participants	37.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 18: Extreme anxious/depress	2.4 percentage of participants	3.1 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 24: Not anxious/depress	63.8 percentage of participants	61.0 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 24: Moderate anxious/depress	33.8 percentage of participants	36.2 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 24: Extreme anxious/depress	2.4 percentage of participants	2.8 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 36: Not anxious/depress	64.0 percentage of participants	61.6 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 36: Moderate anxious/depress	33.3 percentage of participants	35.4 percentage of participants
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain FU Month 36: Extreme anxious/depress	2.6 percentage of participants	3.0 percentage of participants

SECONDARY outcome

Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Population: Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=36 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Trough Serum Concentration (Cmin) of Pertuzumab Cycle 1	68.0 micrograms per milliliter (mcg/mL) Standard Deviation 16.6	—
Trough Serum Concentration (Cmin) of Pertuzumab Cycle 10	88.1 micrograms per milliliter (mcg/mL) Standard Deviation 34.4	—
Trough Serum Concentration (Cmin) of Pertuzumab Cycle 15	95.5 micrograms per milliliter (mcg/mL) Standard Deviation 51.5	—

SECONDARY outcome

Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=36 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=34 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Cmin of Trastuzumab Cycle 1	32.1 mcg/mL Standard Deviation 13.4	34.1 mcg/mL Standard Deviation 11.4
Cmin of Trastuzumab Cycle 10	65.0 mcg/mL Standard Deviation 39.6	68.4 mcg/mL Standard Deviation 23.0
Cmin of Trastuzumab Cycle 15	72.9 mcg/mL Standard Deviation 46.1	71.0 mcg/mL Standard Deviation 30.4

SECONDARY outcome

Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=36 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Peak Serum Concentration (Cmax) of Pertuzumab Cycle 1	237 mcg/mL Standard Deviation 118	—
Peak Serum Concentration (Cmax) of Pertuzumab Cycle 10	222 mcg/mL Standard Deviation 92.2	—
Peak Serum Concentration (Cmax) of Pertuzumab Cycle 15	206 mcg/mL Standard Deviation 94.9	—

SECONDARY outcome

Timeframe: Cycles 1, 10 and 15 (Cycle length=21 days)

Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.

Outcome measures

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=36 Participants Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=34 Participants Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Cmax of Trastuzumab Cycle 1	180 mcg/mL Standard Deviation 81.0	190 mcg/mL Standard Deviation 51.6
Cmax of Trastuzumab Cycle 10	219 mcg/mL Standard Deviation 94.6	225 mcg/mL Standard Deviation 70.7
Cmax of Trastuzumab Cycle 15	187 mcg/mL Standard Deviation 95.1	234 mcg/mL Standard Deviation 73.5

Adverse Events

Pertuzumab + Trastuzumab + Chemotherapy

Serious events: 792 serious events

Other events: 2353 other events

Deaths: 205 deaths

Placebo + Trastuzumab + Chemotherapy

Serious events: 686 serious events

Other events: 2374 other events

Deaths: 247 deaths

Serious adverse events

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 participants at risk Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 participants at risk Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Blood and lymphatic system disorders AGRANULOCYTOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders ANAEMIA	0.42% 10/2364 • Number of events 14 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.33% 8/2405 • Number of events 10 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders FEBRILE BONE MARROW APLASIA	0.38% 9/2364 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.33% 8/2405 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	8.9% 211/2364 • Number of events 239 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	8.1% 196/2405 • Number of events 215 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders IDIOPATHIC CYTOPENIA OF UNDETERMINED SIGNIFICANCE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders LEUKOPENIA	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders MICROANGIOPATHIC HAEMOLYTIC ANAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders MYELOSUPPRESSION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders NEUTROPENIA	1.1% 25/2364 • Number of events 30 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	1.4% 34/2405 • Number of events 39 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders PANCYTOPENIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ACUTE CORONARY SYNDROME	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ANGINA PECTORIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders AORTIC VALVE DISEASE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ARRHYTHMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIAL FIBRILLATION	0.25% 6/2364 • Number of events 8 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.25% 6/2405 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIAL FLUTTER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIAL THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders BRADYCARDIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIAC ARREST	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIAC FAILURE	1.9% 44/2364 • Number of events 48 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	1.2% 28/2405 • Number of events 31 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIAC FAILURE CHRONIC	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIOGENIC SHOCK	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CORONARY ARTERY STENOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Endocrine disorders GOITRE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders DILATED CARDIOMYOPATHY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders EXTRASYSTOLES	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders HYPERTENSIVE HEART DISEASE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders METABOLIC CARDIOMYOPATHY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders MITRAL VALVE DISEASE	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders MYOCARDIAL INFARCTION	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders PALPITATIONS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders PERICARDIAL EFFUSION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders SINUS BRADYCARDIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders SINUS NODE DYSFUNCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders STRESS CARDIOMYOPATHY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders PAPILLOEDEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders TACHYCARDIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders TACHYCARDIA PAROXYSMAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders VENTRICULAR FIBRILLATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Cardiac disorders VENTRICULAR HYPOKINESIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Congenital, familial and genetic disorders CONGENITAL APLASIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Congenital, familial and genetic disorders PYLORIC STENOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Ear and labyrinth disorders EXTERNAL EAR INFLAMMATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Ear and labyrinth disorders TYMPANIC MEMBRANE PERFORATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Ear and labyrinth disorders VERTIGO	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Ear and labyrinth disorders VESTIBULAR DISORDER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Endocrine disorders HYPERTHYROIDISM	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Endocrine disorders INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Endocrine disorders THYROID DISORDER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders OPTIC NERVE DISORDER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders VISUAL ACUITY REDUCED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders VISUAL FIELD DEFECT	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ABDOMINAL PAIN	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.29% 7/2405 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ANAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders CYST	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders COLITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders CONSTIPATION	0.17% 4/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DIARRHOEA	2.5% 58/2364 • Number of events 67 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.75% 18/2405 • Number of events 18 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DUODENAL PERFORATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DUODENAL ULCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DUODENAL ULCER PERFORATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ENTERITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ENTEROCOLITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders FEMORAL HERNIA STRANGULATED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTRIC ULCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTRITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.04% 1/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROINTESTINAL TOXICITY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders HAEMORRHOIDS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ILEUS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INGUINAL HERNIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INTESTINAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INTRA-ABDOMINAL HAEMATOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders INTUSSUSCEPTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders NAUSEA	0.76% 18/2364 • Number of events 18 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.58% 14/2405 • Number of events 16 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders NEUTROPENIC COLITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders OEDEMA MOUTH	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders OESOPHAGEAL PAIN	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ORAL PAIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders PANCREATITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders PANCREATITIS ACUTE	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders PROCTITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders STOMATITIS	0.30% 7/2364 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders SUBILEUS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders TOOTHACHE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders VOMITING	0.80% 19/2364 • Number of events 20 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.62% 15/2405 • Number of events 21 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders ASTHENIA	0.08% 2/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders CHEST PAIN	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.25% 6/2405 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders CHILLS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders DEVICE RELATED THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders FATIGUE	0.30% 7/2364 • Number of events 10 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders GENERALISED OEDEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders INFLUENZA LIKE ILLNESS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders MALAISE	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders MASS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders MUCOSAL INFLAMMATION	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders NECROSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders OEDEMA PERIPHERAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders PYREXIA	1.7% 40/2364 • Number of events 41 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	1.9% 46/2405 • Number of events 53 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders BILIARY COLIC	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders CHOLANGITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders CHOLELITHIASIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders HEPATIC FAILURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Immune system disorders ANAPHYLACTIC REACTION	0.04% 1/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Immune system disorders ANAPHYLACTIC SHOCK	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Immune system disorders DRUG HYPERSENSITIVITY	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Immune system disorders HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Immune system disorders HYPERSENSITIVITY	0.47% 11/2364 • Number of events 11 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ABDOMINAL ABSCESS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ABDOMINAL INFECTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ABSCESS LIMB	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ABSCESS ORAL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ACUTE HEPATITIS B	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ANAL ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ANORECTAL INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations APPENDICITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations APPENDICITIS PERFORATED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations BACTERAEMIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations BACTERIAL INFECTION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations BREAST ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations BREAST CELLULITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations BRONCHITIS	0.30% 7/2364 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CELLULITIS	0.63% 15/2364 • Number of events 15 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.54% 13/2405 • Number of events 13 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CHRONIC SINUSITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CLOSTRIDIUM COLITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DEVICE RELATED INFECTION	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DEVICE RELATED SEPSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DIARRHOEA INFECTIOUS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DISSEMINATED TUBERCULOSIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DIVERTICULITIS	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.25% 6/2405 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations DIVERTICULITIS INTESTINAL PERFORATED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ENDOCARDITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ERYSIPELAS	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ESCHERICHIA INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations GASTROENTERITIS	0.34% 8/2364 • Number of events 8 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations GASTROENTERITIS VIRAL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations H1N1 INFLUENZA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations HEPATITIS B REACTIVATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations HERPES ZOSTER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations HERPES ZOSTER DISSEMINATED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations INFECTED LYMPHOCELE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations INFECTED SEROMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations INFECTION	0.30% 7/2364 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.25% 6/2405 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations INFLUENZA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations LARYNGITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations LARYNGOPHARYNGITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations LOCALISED INFECTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations LYMPHANGITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations MASTITIS	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations NASOPHARYNGITIS	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations NEUTROPENIC INFECTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations NEUTROPENIC SEPSIS	0.47% 11/2364 • Number of events 12 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations ORAL CANDIDIASIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations OTITIS MEDIA ACUTE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PARONYCHIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PERIODONTITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PERITONSILLAR ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PHARYNGITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PHLEBITIS INFECTIVE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PLEURAL INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA	0.80% 19/2364 • Number of events 19 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	1.1% 27/2405 • Number of events 28 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA ASPIRATION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA PNEUMOCOCCAL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA PSEUDOMONAL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PNEUMONIA STREPTOCOCCAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations POSTOPERATIVE ABSCESS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PSEUDOMONAL BACTERAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PYELONEPHRITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations RECTAL ABSCESS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations RESPIRATORY TRACT INFECTION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SALPINGO-OOPHORITIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SEPSIS	0.30% 7/2364 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.37% 9/2405 • Number of events 11 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SEPTIC SHOCK	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SERRATIA INFECTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SINUSITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SKIN INFECTION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SOFT TISSUE INFECTION	0.13% 3/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations SUBCUTANEOUS ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations TONSILLITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations TOOTH INFECTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.38% 9/2364 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.33% 8/2405 • Number of events 8 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations URINARY TRACT INFECTION	0.34% 8/2364 • Number of events 11 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.37% 9/2405 • Number of events 10 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations UROSEPSIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations VARICELLA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations VASCULAR DEVICE INFECTION	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.25% 6/2405 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations VIRAL INFECTION	0.08% 2/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations VULVAL ABSCESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations WOUND INFECTION	0.21% 5/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications AVULSION FRACTURE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications BREAST PROCEDURAL COMPLICATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications CONCUSSION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications FALL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications FRACTURED SACRUM	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications ILIUM FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications INTENTIONAL OVERDOSE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications PNEUMOCONIOSIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications PNEUMOTHORAX TRAUMATIC	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications PULMONARY RADIATION INJURY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications RADIATION SKIN INJURY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications RIB FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications SEROMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications SHOULDER FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications SKIN LACERATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications WRIST FRACTURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations BLOOD CREATININE INCREASED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations BLOOD GLUCOSE FLUCTUATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations EJECTION FRACTION DECREASED	0.59% 14/2364 • Number of events 15 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.42% 10/2405 • Number of events 10 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations LIVER FUNCTION TEST INCREASED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations NEUTROPHIL COUNT DECREASED	0.30% 7/2364 • Number of events 8 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations PLATELET COUNT DECREASED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations TROPONIN INCREASED	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations WEIGHT DECREASED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.08% 2/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders DECREASED APPETITE	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders DEHYDRATION	0.80% 19/2364 • Number of events 19 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders FLUID RETENTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPERKALAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOKALAEMIA	0.34% 8/2364 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPONATRAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders MYALGIA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders OSTEONECROSIS OF JAW	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders SJOGREN'S SYNDROME	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE LEUKAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA GASTRIC	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOSARCOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) APPENDIX CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B PRECURSOR TYPE ACUTE LEUKAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.25% 6/2364 • Number of events 8 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.37% 9/2405 • Number of events 11 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN BREAST NEOPLASM	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM OF SKIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BILE DUCT ADENOCARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE GIANT CELL TUMOUR BENIGN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEN'S DISEASE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST ANGIOSARCOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CARDIAC MYXOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHONDROSARCOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CLEAR CELL RENAL CELL CARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CONJUNCTIVAL MELANOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DERMATOFIBROSARCOMA PROTUBERANS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DIFFUSE LARGE B-CELL LYMPHOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL ADENOCARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ESSENTIAL THROMBOCYTHAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICULAR LYMPHOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GANGLIONEUROMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC NEOPLASM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL CARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTRADUCTAL PROLIFERATIVE BREAST LESION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LENTIGO MALIGNA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.38% 9/2364 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOCYTIC LYMPHOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.37% 9/2405 • Number of events 9 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA IN SITU	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM OF RENAL PELVIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PERITONEAL NEOPLASM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.13% 3/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC MALIGNANT MELANOMA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC UTERINE CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MONOCLONAL GAMMOPATHY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELOID LEUKAEMIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM OF ORBIT	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEURILEMMOMA BENIGN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA METASTATIC	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA OF THE SKIN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER METASTATIC	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.17% 4/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN EPITHELIAL CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.29% 7/2405 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PAPILLARY THYROID CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR BENIGN	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PELVIC NEOPLASM	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL ADENOCARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RETINAL MELANOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SECOND PRIMARY MALIGNANCY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE LEIOMYOSARCOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOFT TISSUE SARCOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF THE CERVIX	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF THE TONGUE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE CANCER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) VULVAL CANCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders ATAXIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders AUTONOMIC NERVOUS SYSTEM IMBALANCE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders DIZZINESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders EMBOLIC STROKE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders HEAD TITUBATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders HEADACHE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders INTERCOSTAL NEURALGIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders INTRACRANIAL ANEURYSM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders LACUNAR INFARCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders MIGRAINE WITH AURA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders NEURALGIC AMYOTROPHY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders NEUROPATHY PERIPHERAL	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders NEUROTOXICITY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders PARAESTHESIA	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders PSYCHOGENIC SEIZURE	0.04% 1/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders SCIATICA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders SEIZURE	0.13% 3/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders SUNCT SYNDROME	0.04% 1/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders SYNCOPE	0.55% 13/2364 • Number of events 13 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders THALAMIC INFARCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders TRIGEMINAL NEURALGIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Product Issues DEVICE BREAKAGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Product Issues DEVICE DISLOCATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Product Issues DEVICE EXTRUSION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders ANXIETY	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders DELUSIONAL DISORDER, UNSPECIFIED TYPE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders DEPRESSION	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders HYPOMANIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders MAJOR DEPRESSION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders MANIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders MENTAL DISORDER	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders PERSISTENT DEPRESSIVE DISORDER	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders PERSONALITY CHANGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders PSYCHOTIC DISORDER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders REACTIVE PSYCHOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders SUICIDE ATTEMPT	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders DYSURIA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders RENAL COLIC	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders RENAL FAILURE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders RENAL IMPAIRMENT	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders URETERIC OBSTRUCTION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders URETEROLITHIASIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders URINARY INCONTINENCE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Renal and urinary disorders URINARY RETENTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders ABNORMAL UTERINE BLEEDING	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders BREAST INFLAMMATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders BREAST PAIN	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders CERVICAL POLYP	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders HEAVY MENSTRUAL BLEEDING	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders OVARIAN CYST	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders PELVIC CYST	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.04% 1/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders COUGH	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.25% 6/2364 • Number of events 6 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.29% 7/2405 • Number of events 7 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders LUNG CONSOLIDATION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders NASAL OEDEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL DISCOMFORT	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders ACUTE FEBRILE NEUTROPHILIC DERMATOSIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE GENERALISED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders ERYTHEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders RASH	0.21% 5/2364 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders SKIN ULCER	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders TOXIC SKIN ERUPTION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders URTICARIA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Surgical and medical procedures ABORTION INDUCED	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Surgical and medical procedures BREAST TUMOUR EXCISION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Surgical and medical procedures HOSPITALISATION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Surgical and medical procedures SKIN NEOPLASM EXCISION	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders AXILLARY VEIN THROMBOSIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders DEEP VEIN THROMBOSIS	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders EMBOLISM	0.13% 3/2364 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders EMBOLISM VENOUS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HAEMATOMA	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HAEMORRHAGE	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HYPERTENSION	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.17% 4/2405 • Number of events 4 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HYPOTENSION	0.08% 2/2364 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.21% 5/2405 • Number of events 5 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders JUGULAR VEIN THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders LYMPHOEDEMA	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders PHLEBITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.04% 1/2405 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders THROMBOPHLEBITIS	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.08% 2/2405 • Number of events 2 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders THROMBOSIS	0.00% 0/2364 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.12% 3/2405 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders VARICOSE VEIN	0.04% 1/2364 • Number of events 1 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders VENOUS THROMBOSIS LIMB	0.13% 3/2364 • Number of events 3 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	0.00% 0/2405 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.

Other adverse events

Measure	Pertuzumab + Trastuzumab + Chemotherapy n=2364 participants at risk Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Placebo + Trastuzumab + Chemotherapy n=2405 participants at risk Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
Blood and lymphatic system disorders ANAEMIA	28.2% 667/2364 • Number of events 833 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	23.6% 567/2405 • Number of events 717 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders LEUKOPENIA	9.3% 220/2364 • Number of events 484 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	9.8% 235/2405 • Number of events 535 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Blood and lymphatic system disorders NEUTROPENIA	25.0% 592/2364 • Number of events 1039 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	23.1% 556/2405 • Number of events 1007 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders DRY EYE	6.0% 141/2364 • Number of events 146 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	4.7% 113/2405 • Number of events 118 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Eye disorders LACRIMATION INCREASED	13.2% 312/2364 • Number of events 334 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	13.5% 324/2405 • Number of events 347 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ABDOMINAL PAIN	12.1% 285/2364 • Number of events 369 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.9% 261/2405 • Number of events 337 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	10.3% 244/2364 • Number of events 304 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	9.1% 220/2405 • Number of events 297 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders CONSTIPATION	29.3% 692/2364 • Number of events 1028 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	31.7% 762/2405 • Number of events 1117 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DIARRHOEA	70.5% 1667/2364 • Number of events 3368 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	45.4% 1091/2405 • Number of events 1791 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DRY MOUTH	6.3% 150/2364 • Number of events 166 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.8% 140/2405 • Number of events 176 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders DYSPEPSIA	13.9% 328/2364 • Number of events 378 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	14.2% 341/2405 • Number of events 406 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.2% 124/2364 • Number of events 144 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	4.6% 110/2405 • Number of events 124 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders HAEMORRHOIDS	7.9% 186/2364 • Number of events 218 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.2% 126/2405 • Number of events 140 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders NAUSEA	69.3% 1639/2364 • Number of events 2960 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	65.8% 1582/2405 • Number of events 2900 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders STOMATITIS	28.2% 666/2364 • Number of events 996 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	23.9% 574/2405 • Number of events 828 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Gastrointestinal disorders VOMITING	32.6% 771/2364 • Number of events 1231 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	30.2% 727/2405 • Number of events 1178 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders ASTHENIA	21.8% 515/2364 • Number of events 958 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	20.9% 502/2405 • Number of events 917 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders FATIGUE	49.1% 1160/2364 • Number of events 1779 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	44.7% 1074/2405 • Number of events 1629 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders INFLUENZA LIKE ILLNESS	5.3% 126/2364 • Number of events 158 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.0% 120/2405 • Number of events 152 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders MUCOSAL INFLAMMATION	23.5% 555/2364 • Number of events 751 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	19.0% 458/2405 • Number of events 600 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders OEDEMA	6.0% 141/2364 • Number of events 162 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.4% 155/2405 • Number of events 176 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders OEDEMA PERIPHERAL	17.2% 406/2364 • Number of events 494 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	20.4% 491/2405 • Number of events 588 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders PAIN	6.8% 160/2364 • Number of events 189 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.8% 164/2405 • Number of events 200 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
General disorders PYREXIA	19.2% 455/2364 • Number of events 646 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	18.3% 439/2405 • Number of events 617 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations CONJUNCTIVITIS	6.4% 151/2364 • Number of events 165 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.4% 130/2405 • Number of events 136 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations NASOPHARYNGITIS	13.7% 323/2364 • Number of events 482 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	12.1% 292/2405 • Number of events 425 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations RHINITIS	6.1% 144/2364 • Number of events 169 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.0% 120/2405 • Number of events 135 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	7.8% 184/2364 • Number of events 227 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	7.3% 175/2405 • Number of events 225 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Infections and infestations URINARY TRACT INFECTION	7.8% 185/2364 • Number of events 234 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.7% 161/2405 • Number of events 195 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Injury, poisoning and procedural complications RADIATION SKIN INJURY	12.6% 297/2364 • Number of events 304 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.9% 261/2405 • Number of events 265 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations ALANINE AMINOTRANSFERASE INCREASED	9.7% 230/2364 • Number of events 293 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.2% 246/2405 • Number of events 329 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	6.4% 152/2364 • Number of events 183 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.7% 161/2405 • Number of events 214 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations EJECTION FRACTION DECREASED	7.4% 175/2364 • Number of events 212 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	8.8% 212/2405 • Number of events 272 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations NEUTROPHIL COUNT DECREASED	13.7% 325/2364 • Number of events 694 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	13.7% 329/2405 • Number of events 701 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations WEIGHT DECREASED	8.3% 197/2364 • Number of events 208 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	3.5% 83/2405 • Number of events 88 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations WEIGHT INCREASED	2.6% 62/2364 • Number of events 64 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.7% 137/2405 • Number of events 147 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Investigations WHITE BLOOD CELL COUNT DECREASED	9.9% 235/2364 • Number of events 573 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	8.6% 208/2405 • Number of events 493 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders DECREASED APPETITE	24.1% 570/2364 • Number of events 936 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	20.3% 488/2405 • Number of events 756 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOKALAEMIA	6.4% 151/2364 • Number of events 193 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	4.0% 97/2405 • Number of events 112 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	6.2% 146/2364 • Number of events 178 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	3.3% 79/2405 • Number of events 95 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders ARTHRALGIA	32.4% 765/2364 • Number of events 1029 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	36.0% 867/2405 • Number of events 1259 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders BACK PAIN	9.0% 213/2364 • Number of events 254 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.0% 241/2405 • Number of events 272 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders BONE PAIN	9.6% 228/2364 • Number of events 290 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.7% 258/2405 • Number of events 348 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	9.3% 221/2364 • Number of events 274 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.2% 125/2405 • Number of events 152 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders MYALGIA	26.2% 620/2364 • Number of events 829 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	29.8% 716/2405 • Number of events 975 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.0% 237/2364 • Number of events 276 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.7% 257/2405 • Number of events 315 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders DIZZINESS	11.5% 272/2364 • Number of events 349 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	11.7% 281/2405 • Number of events 365 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders DYSGEUSIA	17.7% 419/2364 • Number of events 512 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	14.6% 352/2405 • Number of events 481 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders HEADACHE	22.8% 539/2364 • Number of events 798 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	23.7% 569/2405 • Number of events 811 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders NEUROPATHY PERIPHERAL	15.7% 372/2364 • Number of events 431 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	15.5% 373/2405 • Number of events 421 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders PARAESTHESIA	11.8% 279/2364 • Number of events 342 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	10.1% 244/2405 • Number of events 281 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	18.1% 427/2364 • Number of events 504 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	17.5% 422/2405 • Number of events 485 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Nervous system disorders TASTE DISORDER	8.7% 205/2364 • Number of events 231 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	7.3% 175/2405 • Number of events 193 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders ANXIETY	6.9% 162/2364 • Number of events 176 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	4.9% 117/2405 • Number of events 121 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Psychiatric disorders INSOMNIA	17.4% 412/2364 • Number of events 465 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	17.0% 410/2405 • Number of events 466 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Reproductive system and breast disorders BREAST PAIN	5.2% 122/2364 • Number of events 136 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	4.6% 110/2405 • Number of events 119 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders COUGH	15.9% 377/2364 • Number of events 473 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	14.8% 357/2405 • Number of events 445 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	12.0% 284/2364 • Number of events 331 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	11.3% 272/2405 • Number of events 321 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	18.3% 433/2364 • Number of events 518 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	13.7% 329/2405 • Number of events 417 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	9.3% 219/2364 • Number of events 260 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	7.3% 176/2405 • Number of events 203 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	8.1% 192/2364 • Number of events 210 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.7% 136/2405 • Number of events 151 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders ALOPECIA	67.4% 1594/2364 • Number of events 1601 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	68.0% 1635/2405 • Number of events 1647 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders DRY SKIN	13.3% 315/2364 • Number of events 351 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	11.4% 274/2405 • Number of events 297 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders ERYTHEMA	10.2% 241/2364 • Number of events 283 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	9.3% 224/2405 • Number of events 282 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	7.4% 176/2364 • Number of events 184 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	7.4% 178/2405 • Number of events 181 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders NAIL DISORDER	12.0% 283/2364 • Number of events 302 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	11.8% 283/2405 • Number of events 299 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	9.3% 220/2364 • Number of events 241 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.6% 159/2405 • Number of events 170 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders PRURITUS	14.5% 342/2364 • Number of events 415 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	9.3% 223/2405 • Number of events 281 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Skin and subcutaneous tissue disorders RASH	26.1% 618/2364 • Number of events 802 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	20.6% 495/2405 • Number of events 646 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HOT FLUSH	20.8% 492/2364 • Number of events 532 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	21.5% 518/2405 • Number of events 574 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders HYPERTENSION	4.0% 95/2364 • Number of events 107 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	5.1% 123/2405 • Number of events 131 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Vascular disorders LYMPHOEDEMA	5.8% 137/2364 • Number of events 140 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.	6.8% 164/2405 • Number of events 169 • From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years) All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.

Additional Information

Medical Communications

Hoffmann-La Roche

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Email: genentech@druginfo.com

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• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER