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| ID | Type | Description | Link |
|---|---|---|---|
| TOC4939G | Other Identifier | Genentech | |
| 2010-022902-41 | EudraCT Number | ||
| BIG 4-11 | Other Identifier | Breast International Group |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Breast International Group | OTHER |
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This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Experimental | Participants will receive 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). |
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| Placebo + Trastuzumab + Chemotherapy | Placebo Comparator | Participants will receive placebo matching 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]). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | 5-Fluorouracil will be administered as per the schedule specified in the respective arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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) |
| 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 | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute ? Bisgrove | Scottsdale | Arizona | 85258 | United States | ||
| Providence Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41934626 | Derived | Agostinetto E, Gentile G, Samy F, Di Cosimo S, Aftimos P, Ponde N, Eiger D, Lambertini M, Cameron D, Kiermaier A, Bailey A, Viale G, Loi S, Piccart M, de Azambuja E. The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a Sub-analysis of the APHINITY trial. J Natl Cancer Inst. 2026 Apr 3:djag095. doi: 10.1093/jnci/djag095. Online ahead of print. | |
| 39259927 |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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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.
Overall, 4804 patients were randomized in the study, 2400 in the Pertuzumab arm and 2404 in the Placebo arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Carboplatin | Drug | Carboplatin will be administered as per the schedule specified in the respective arm. |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered as per the schedule specified in the respective arm. |
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| Docetaxel | Drug | Docetaxel will be administered as per the schedule specified in the respective arm. |
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| Doxorubicin | Drug | Doxorubicin will be administered as per the schedule specified in the respective arm. |
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| Epirubicin | Drug | Epirubicin will be administered as per the schedule specified in the respective arm. |
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| Paclitaxel | Drug | Paclitaxel will be administered as per the schedule specified in the respective arm. |
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| Pertuzumab | Drug | Pertuzumab will be administered as per the schedule specified in the respective arm. |
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| Placebo | Drug | Placebo will be administered as per the schedule specified in the respective arm. |
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| Trastuzumab | Drug | Trastuzumab will be administered as per the schedule specified in the respective arm. |
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| 6, 8, and 10 years |
| Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 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). | 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) |
| 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 | 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). | 3 years |
| 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 | 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. | 6, 8, and 10 years |
| Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 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. | 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) |
| 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 | 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. | 3 years |
| 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 | 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. | 6, 8, and 10 years |
| Percentage of Participants Who Died, First Interim Overall Survival Analysis | Percentage of participants who died due to any cause is reported. | 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) |
| Percentage of Participants Who Died, Final Overall Survival Analysis | Percentage of participants who died due to any cause is reported. | Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years) |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 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. | 3 years |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 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. | 6, 8, and 10 years |
| Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence. | 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) |
| 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 | 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. | 3 years |
| 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 | 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. | 6, 8, and 10 years |
| Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence. | Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) |
| 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 | 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. | 3 years |
| 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 | 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. | 6, 8, and 10 years |
| Percentage of Participants With Primary Cardiac Event, Primary Analysis | 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. | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
| Percentage of Participants With Primary Cardiac Event, Final Analysis | 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. | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
| Percentage of Participants With Secondary Cardiac Event, Primary Analysis | 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). | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
| Percentage of Participants With Secondary Cardiac Event, Final Analysis | 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). | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
| Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | 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. | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
| Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | 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. | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
| 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 | 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. | 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 |
| Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | 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. | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
| Trough Serum Concentration (Cmin) of Pertuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) |
| Cmin of Trastuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) |
| Peak Serum Concentration (Cmax) of Pertuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) |
| Cmax of Trastuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) |
| Everett |
| California |
| 98208 |
| United States |
| Marin Cancer Care Inc | Greenbrae | California | 94904 | United States |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | United States |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States |
| Southern California Kaiser Permanente | San Diego | California | 92108 | United States |
| K. Permanente - San Fransisco | San Francisco | California | 94115 | United States |
| K. Permanente - San Jose | San Jose | California | 95119 | United States |
| K. Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| K. Permanente - S. San Fran | South San Francisco | California | 94080 | United States |
| Kaiser Permanente | Vallejo | California | 94589 | United States |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Rocky Mountain Cancer Center - Denver | Denver | Colorado | 80220 | United States |
| Lutheran Hematology &Oncology | Wheat Ridge | Colorado | 80033 | United States |
| Eastern Ct Hema/Onco Assoc | Norwich | Connecticut | 06360 | United States |
| Washington Cancer Institute at MedStar Washington Hospital Center. | Washington D.C. | District of Columbia | 20010 | United States |
| Georgetown U | Washington D.C. | District of Columbia | 20057 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Memorial Cancer Institute | Hollywood | Florida | 33021 | United States |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | United States |
| Cancer Specialists | Jacksonville | Florida | 32256 | United States |
| Ocala Oncology Center | Ocala | Florida | 34474 | United States |
| Memorial Breast Cancer Center | Pembroke Pines | Florida | 33028 | United States |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists, Research Department | West Palm Beach | Florida | 33401 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Uni of Chicago | Chicago | Illinois | 60637 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Loyola University Med Center | Maywood | Illinois | 60153 | United States |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615-7828 | United States |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Carle Foundation | Urbana | Illinois | 61801 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| Cancer Center of Acadiana at Lafayette General | Lafayette | Louisiana | 70503 | United States |
| Cancer Care of Maine | Bangor | Maine | 04401 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Weinberg CA Inst Franklin Sq | Baltimore | Maryland | 21237 | United States |
| Maryland Oncology & Hematology, PA | Bethesda | Maryland | 20817 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deac Med Ctr | Boston | Massachusetts | 02215 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Berkshire Hematology, Oncology Pc | Pittsfield | Massachusetts | 01201 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Southdale Cancer Clinic | Edina | Minnesota | 55414 | United States |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | United States |
| Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | United States |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Heartland CCOP/Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Cancer Alliance of Nebraska | Lincoln | Nebraska | 68510 | United States |
| Cancer Alliance of Nebraska | Omaha | Nebraska | 68106 | United States |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Roswell Park Cancer Inst. | Buffalo | New York | 14263 | United States |
| Mount Sinai Beth Israel Medical Center | New York | New York | 10003 | United States |
| Mount Sinai Beth Israel Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| The Mark H. Zangmeister Ctr | Columbus | Ohio | 43219 | United States |
| Dayton Clinical Oncology Prog | Dayton | Ohio | 45420 | United States |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623-3536 | United States |
| Northwest Cancer Specialists - Portland (NE Hoyt St) | Portland | Oregon | 97213 | United States |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | United States |
| Roper Bon Secours St. Francis Cancer Center | Charleston | South Carolina | 29414 | United States |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | United States |
| University of Missouri-Columbia | Columbia | South Carolina | 65203 | United States |
| Cancer Centers of the Carolina | Greenville | South Carolina | 29615 | United States |
| Sanford USD School of Medicine | Sioux Falls | South Dakota | 57104 | United States |
| Tennessee Oncology , PLLC - Chattanooga | Chattanooga | Tennessee | 37403 | United States |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230 | United States |
| Texas Oncology - DFW at Dallas Presbyterian Hospital | Dallas | Texas | 75231 | United States |
| Texas Oncology - DFW | Dallas | Texas | 75246 | United States |
| Texas Oncology-El Paso Cancer Treatment Center Grandview | El Paso | Texas | 79902 | United States |
| Texas Oncology - DFW Fort Worth | Fort Worth | Texas | 76104 | United States |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Texas Oncology, P.A. - Garland | Garland | Texas | 77060 | United States |
| Texas Oncology - Houston (Gessner) | Houston | Texas | 77024 | United States |
| Cancer Care Centers of South Texas-HOAST - San Antonio | New Braunfels | Texas | 78130 | United States |
| Texas Oncology - DFW Plano | Plano | Texas | 75075 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | United States |
| Wellmonth Physician Services | Bristol | Virginia | 24201 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Providence St. Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26506-9162 | United States |
| Green Bay Oncology/St. Mary?s Hospital | Green Bay | Wisconsin | 54301 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Centro Medico San Roque | San Miguel de Tucumán | T4000IAK | Argentina |
| Lismore Base Hospital | Lismore | New South Wales | 2480 | Australia |
| Mater Misericordiae Hospital | Sydney | New South Wales | 2060 | Australia |
| Newcastle Mater Misericordiae Hospital | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Wesley Medical Centre | Auchenflower | Queensland | 4066 | Australia |
| Mater Hospital | Brisbane | Queensland | 4101 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Monash Medical Centre | EAST Bentleigh | Victoria | VIC 3165 | Australia |
| Geelong Hospital | Geelong | Victoria | 3220 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Peter Maccallum Cancer Institute | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Tiroler Landeskrankenanstalten Ges.M.B.H. | Innsbruck | 6020 | Austria |
| Ordensklinikum Linz Barmherzige Schwestern | Linz | 4010 | Austria |
| Lhk Feldkirch | Rankweil | 6830 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg | Salzburg | 5020 | Austria |
| A. Ö. Krankenhaus Der Barmherzigen Brüder | Sankt Veit an der Glan | 9300 | Austria |
| Medizinische Universität Wien; Klinik für Frauenheilkunde | Vienna | 1090 | Austria |
| Medizinische Universität Wien; Klinik für Innere Medizin; Abteilung für Onkologie | Vienna | 1090 | Austria |
| Krankenhaus Der Stadt Wien-Hietzing | Vienna | 1130 | Austria |
| Lkh Vöcklabruck | Vöcklabruck | 4840 | Austria |
| Klinikum Kreuzschwestern Wels | Wels | 4600 | Austria |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| GHdC Site Les Viviers | Charleroi | 6060 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Liège (Sart Tilman) | Liège | 4000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| ZAS Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| UMHAT Tsaritsa Yoanna - ISUL | Sofia | 1527 | Bulgaria |
| SHATO - Sofia | Sofia | 1756 | Bulgaria |
| SHATOD Dr. Marko Antonov Markov-Varna, EOOD | Varna | 9010 | Bulgaria |
| Arthur J.E. Child Comprehensive Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Can Inst | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer Agency, CSI | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BC Cancer ? Surrey | Surrey | British Columbia | V3V 1Z2 | Canada |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Bcca - Vancouver Island Cancer Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Northeastern Ontario | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario | Kingston | Ontario | K7L 5P9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre | Mississauga | Ontario | L5M 2N1 | Canada |
| Southlake Regional Health Center | Newmarket | Ontario | L3Y 2R2 | Canada |
| Ottawa Regional Cancer Centre | Ottawa | Ontario | K1H 1C4 | Canada |
| Niagara Health Systems - St. Catherines General Site | St. Catharines | Ontario | L2R 7C6 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1Z5 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Hopital Maisonneuve- Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Hopital Sacre-Coeur Research Centre | Montreal | Quebec | H4J 1C5 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Hopital du Saint Sacrement | Québec | G1J 1Z4 | Canada |
| INTOP | Providencia | 7501089 | Chile |
| Fundacion Arturo Lopez Perez | Santiago | 7500921 | Chile |
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China |
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China |
| Jilin Cancer Hospital | Changchun | 130012 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Hu Nan Provincial Cancer Hospital | Changsha | 410006 | China |
| Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| Fujian Medical University Union Hospital | Fujian | 350001 | China |
| The 900th Hospital of PLA joint service support force | Fuzhou | 110016 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| Harbin Medical University Cancer Hospital; Dept. of Breast Surgery | Harbin | 150081 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| The 1st Affiliated Hospital of Nanchang Unversity | Nanchang | 330006 | China |
| Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| Changhai Hospital of Shanghai | Shanghai | 200433 | China |
| Hebei Medical University Fourth Hospital | Shijiazhuang | 50011 | China |
| Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430022 | China |
| Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech | Wuhan | 430030 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| Fundacion Cardioinfantil | Bogotá | Colombia |
| Inst. Nacional de Cancerologia | Bogotá | Colombia |
| Hospital Pablo Tobon Uribe | Medellin-Antioquia | Colombia |
| Oncomedica S.A. | Montería | Colombia |
| Uni Hospital Split | Split | 21000 | Croatia |
| General Hospital Varazdin | Varaždin | 42000 | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| MULTISCAN, s.r.o., Radiologicke centrum Pardubice | Pardubice | 532 03 | Czechia |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Sydvestjysk Sygehus Esbjerg | Esbjerg | 6700 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Nordsjællands Hospital, Hillerød, Onkologisk Afdeling | Hillerød | 3400 | Denmark |
| Sjællands Universitetshospital, Næstved | Næstved | 4700 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| Sygehus Syd Roskilde | Roskilde | 4000 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Hospital Oncologia | El Salvador | 01101 | El Salvador |
| Clinique De L Europe | Amiens | 80090 | France |
| ICO Paul Papin | Angers | 49000 | France |
| HOP Prive Arras Les Bonnettes | Arras | 62012 | France |
| Institut Sainte Catherine | Avignon | 84000 | France |
| ICONE | Bezannes | 51430 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord | Bordeaux | 33300 | France |
| Hopital Augustin Morvan | Brest | 29200 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Leonard De Vinci | Dechy | 59187 | France |
| Centre Georges-François Lecler | Dijon | 21034 | France |
| Institut Daniel Hollard | Grenoble | 38000 | France |
| Centre Hospitalier Departemental Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Clinique des Ormeaux | Le Havre | 76600 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hopital Dupuytren | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Polyclinique De Gentilly | Nancy | 54100 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut de cancerologie du Gard | Nîmes | 30029 | France |
| Institut Curie | Paris | 75231 | France |
| Ch Pitie Salpetriere | Paris | 75651 | France |
| Polyclinique Francheville | Périgueux | 24000 | France |
| Clinique Armoricaine Radiologie | Plérin | 22190 | France |
| Chu De Poitiers | Poitiers | 86021 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| ICL | Saint Prient En Jarez | 42271 | France |
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
| Ico Rene Gauducheau | Saint-Herblain | 44805 | France |
| Institut d'oncologie de l'Orangerie | Strasbourg | 67010 | France |
| Hopital Hautepierre | Strasbourg | 67098 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| Gesundheitszentrum St. Marien GmbH | Amberg | 92224 | Germany |
| Hochwaldkrankenhaus | Bad Nauheim | 61231 | Germany |
| Praxis Dr. Schoenegg | Berlin | 10719 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche | Berlin | 14169 | Germany |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | 33604 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Klinikum Sindelfingen-Böblingen | Böblingen | 71032 | Germany |
| Praxis Dr. Ralf Lorenz | Braunschweig | 38100 | Germany |
| Hämato-Onkologie im Medicum/Home | Bremen | 28209 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe | Cologne | 50931 | Germany |
| St. Elisabeth Krankenhaus Köln GmbH | Cologne | 50935 | Germany |
| DONAU ISAR Klinikum Deggendorf | Deggendorf | 94469 | Germany |
| St. Johannes-Hospital | Dortmund | 44137 | Germany |
| Universitätsklinikum "Carl Gustav Carus" | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Luisenkrankenhaus GmbH & Co. KG., Brustzentrum | Düsseldorf | 40235 | Germany |
| Praxis für Hamatologie und Onkologie | Erfurt | 99085 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Klinik Johann Wolfgang von Goethe Uni | Frankfurt | 60596 | Germany |
| Städtische Kliniken Frankfurt am Main Höchst | Frankfurt | 65929 | Germany |
| Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus | Frankfurt am Main | 60389 | Germany |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Dres.Jochen Wilke und Harald Wagner | Fürth | 90766 | Germany |
| Universitätsklinikum Greifswald | Greifswald | 17475 | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| SANA Klinikum Hameln-Pyrmont | Hamelin | 31785 | Germany |
| Diakovere Henriettenstift, Frauenklinik | Hanover | 30171 | Germany |
| MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer) | Hanover | 30177 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) | Heidelberg | 69120 | Germany |
| Praxisgemeinschaft | Hildesheim | 31134 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66424 | Germany |
| ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG | Karlsruhe | 76135 | Germany |
| Elisabeth-Krankenhaus Brustzentrum | Kassel | 34117 | Germany |
| Klinikum Kassel GmbH | Kassel | 34125 | Germany |
| UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe | Kiel | 24105 | Germany |
| Klinikum Landshut Frauenklinik | Landshut | 84034 | Germany |
| Sankt Elisabeth Krankenhaus | Leipzig | 04277 | Germany |
| Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) | Lichtenberg | 10367 | Germany |
| Evangelisches Krankenhaus | Ludwigsfelde | 14974 | Germany |
| Universitätsklinikum Schleswig-Holstein / Campus Lübeck | Lübeck | 23562 | Germany |
| Universitätsmedizin Mainz | Mainz | 55131 | Germany |
| Brustzentrum Rhein-Ruhr Servicegesellschaft mbH | Mönchengladbach | 41061 | Germany |
| Klinikum der Universität München | München | 80336 | Germany |
| Rotkreuzklinikum München | München | 80637 | Germany |
| Klinikum rechts der Isar der TU München | München | 81675 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Sana Klinikum Offenbach GmbH | Offenbach | 63069 | Germany |
| Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH | Oldenburg | 26133 | Germany |
| Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum | Ravensburg | 88212 | Germany |
| Oncologianova GmbH | Recklinghausen | 45657 | Germany |
| RoMed Klinikum Rosenheim | Rosenheim | 83022 | Germany |
| Universitätsfrauen- und Poliklinik am Klinikum Suedstadt | Rostock | 18059 | Germany |
| MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin - | Stade | 21680 | Germany |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH | Trier | 54290 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm Am Michelsberg | Ulm | 89075 | Germany |
| Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer | Velbert | 42551 | Germany |
| Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe | Villingen-Schwenningen | 78052 | Germany |
| St. Josefs-Hospital Wiesbaden | Wiesbaden | 65189 | Germany |
| Marien-Hospital Witten | Witten | 58452 | Germany |
| Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker | Würzburg | 97080 | Germany |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Queen Mary Hospital; Dept. of Clinical Oncology | Hong Kong | Hong Kong |
| Queen Mary Hospital; Surgery | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | H-1134 | Hungary |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Békés Megyei Pándy Kálmán Kórház | Gyula | 5700 | Hungary |
| Bács-Kiskun Vármegyei Oktatókórház | Kecskemét | 6000 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6701 | Hungary |
| Cork Uni Hospital | Cork | Ireland |
| Mater Misericordiae Uni Hospital | Dublin | 7 | Ireland |
| St. James Hospital | Dublin | 8 | Ireland |
| Beaumont Hospital | Dublin | 9 | Ireland |
| St Vincent'S Uni Hospital | Dublin | Ireland |
| Galway University Hospital | Galway | Ireland |
| University Hospital Limerick - Oncology | Limerick | Ireland |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Rabin MC | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Sourasky / Ichilov Hospital | Tel Aviv | 6423906 | Israel |
| Ospedale Antonio Perrino | Brindisi | Apulia | 72100 | Italy |
| Campus Universitario S.Venuta | Catanzaro | Calabria | 88100 | Italy |
| AORN'S.G.Moscati | Avellino | Campania | 83100 | Italy |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Campania | 80131 | Italy |
| Ist. Uni Federico Ii | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Ospedale Ramazzini | Carpi | Emilia-Romagna | 41012 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO) | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Divisione Onc Med dell'Azienda | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Ospedale Belcolle Di Viterbo | Viterbo | Lazio | 01100 | Italy |
| Ente Ospedaliero Ospedali Galliera | Genoa | Liguria | 16128 | Italy |
| Az. Osp. Uni Ria San Martino | Genoa | Liguria | 16132 | Italy |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST) | Genoa | Liguria | 16132 | Italy |
| Asst Degli Spedali Civili Di Brescia | Brescia | Lombardy | 25123 | Italy |
| Asst Di Lecco | Lecco | Lombardy | 23900 | Italy |
| Ospedale Mater Salutis | Legnago | Lombardy | 37045 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Milan | Lombardy | 20141 | Italy |
| Policlinico di Monza | Monza | Lombardy | 20052 | Italy |
| IRCCS Fondazione Maugeri | Pavia | Lombardy | 27100 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Az. Osp. Di Busto P.O. Di Saronno | Saronno | Lombardy | 21047 | Italy |
| Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo | Candiolo | Piedmont | 10060 | Italy |
| Ospedale S. Croce Di Fano | Fano | The Marches | 61032 | Italy |
| Ospedale Di Bolzano | Bolzano | Trentino-Alto Adige | 39100 | Italy |
| Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro | Prato | Tuscany | 59100 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia | Perugia | Umbria | 06132 | Italy |
| Azienda Ospedaliera S. Maria - Terni | Terni | Umbria | 05100 | Italy |
| Aichi Cancer Center Hospital, Breast Oncology | Aichi | 464-8681 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| Natl Hosp Org Shikoku | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Gunma University Hospital | Gunma | 371-8511 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery | Kanagawa | 216-8511 | Japan |
| Tokai University Hospital, Breast Surgery | Kanagawa | 259-1193 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Niigata Cancer Ctr Hospital | Niigata | 951-8566 | Japan |
| Iwate Med Univ School of Med | Numakunai | 028-3695 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| Saitama Cancer Center, Breast Oncology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| Shizuoka General Hospital | Shizuoka | 420-8527 | Japan |
| Jichi Medical School | Tochigi | 329-0498 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| Tokyo Metropolitan | Tokyo | 113-8677 | Japan |
| The Cancer Inst. Hosp. of JFCR | Tokyo | 135-8550 | Japan |
| Tokyo Medical Uni. Hospital | Tokyo | 160-0023 | Japan |
| Centro Estatal de Oncología de Campeche | Campehe | Campeche | 24096 | Mexico |
| Fundacion Rodolfo Padilla Padilla A.C. | León | Guanajuato | 37000 | Mexico |
| Núcleo de Especialidades Oncológicas | Guadalajara | Jalisco | 44670 | Mexico |
| Hospital General de México | Mexico City | Mexico CITY (federal District) | 06726 | Mexico |
| Hospital Angeles Metropolitano | Mexico City | Mexico CITY (federal District) | 06760 | Mexico |
| Centro Universitario Contra El Cancer | Monterrey | Nuevo León | 64020 | Mexico |
| Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey | Montrrey | Nuevo León | 64710 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | Oaxaca | 68000 | Mexico |
| Médicos Especialistas en Cáncer SC | Aguascalientes | 20230 | Mexico |
| Centro Estatal De Cancerologia De Durango | Durango | 34000 | Mexico |
| Cancerologia de Queretaro | Querétaro | 76178 | Mexico |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Amphia ziekenhuis, locatie langendijk | Breda | 4819 EV | Netherlands |
| Reinier de Graaf Gasthuis | Delft | 2625 AD | Netherlands |
| Academish Ziekenhuis Maastricht (Azm) | Maastricht | 6229 HX | Netherlands |
| Isala Klinieken | Zwolle | 8011 JW | Netherlands |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Palmerston North Hospital | Palmerston North | 4442 | New Zealand |
| Centro Oncologico America | Panama City | 0834-02723 | Panama |
| The Panama Clinic | Panama City | 32400 | Panama |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 34 | Peru |
| Clinica Anglo Americana - Centro de Investigacion Oncologia CAA | Lima | L27 | Peru |
| Clinica El Golf | San Isidro | L27 Lima | Peru |
| Clinica Peruana Americana | Trujillo | 13011 | Peru |
| University Of Santo Tomas | Manila | 1008 | Philippines |
| Rizal Medical Center | Pasig | 1605 | Philippines |
| Veterans Memorial Medical Ctr | Quezon City, Luzon | 1101 | Philippines |
| Bialostockie Ctr Onkologii | Bialystok | 15-027 | Poland |
| Centrum Onkologii | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gda?sk | 80-214 | Poland |
| Opolskie Centrum Onkologii | Opole | 45-060 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad | Warsaw | 02-781 | Poland |
| NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie | Wieliszew | 05-135 | Poland |
| Emergency University Bucharest Hospital | Bucharest | 050098 | Romania |
| Oncology Inst. Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Euroclinic Center of Oncology SRL | Iași | 700106 | Romania |
| S.I. Russian Oncological Research Center n.a. N.N. Blokhin | Moscow | Moscow Oblast | 115478 | Russia |
| State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | Tatarstan Republic | 420029 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary | Stavropol | 355045 | Russia |
| Tula Regional Oncology Dispensary | Tula | 300053 | Russia |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| National Hospital | Bloemfontein | 9301 | South Africa |
| Wits Donald Gordon Clinical Trial Centre | Johannesburg | 2193 | South Africa |
| Steve Biko Academic Hospital | Pretoria | 0002 | South Africa |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National Uni Hospital | Seoul | 110-744 | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Kyunghee University Hospital | Seoul | 130-702 | South Korea |
| Samsung Medical Centre | Seoul | 135-170 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Hospital General Universitario de Elche | Elche | Alicante | 03202 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell, Barcelona | Barcelona | 08208 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Provincial de Castellon | Castellon | Castellon | 12002 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Cordoba | 14004 | Spain |
| IInstituto Oncologico de San Sebastian, Oncologikoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología | A Coruña | LA Coruna | 15006 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | Lerida | 25198 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia | A Coruña | 15009 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico | Jaén | 23007 | Spain |
| Centro Oncologico MD Anderson Internacional | Madrid | 28033 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28041 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC) | Madrid | 28050 | Spain |
| Hospital General Universitario J.M Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Complejo Hospitalario de Toledo- H. Virgen de la Salud | Toledo | 45004 | Spain |
| Instituto Valenciano Oncologia | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Valencia | 46015 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 40036 | Sweden |
| Uni Hospital Linkoeping | Linköping | 58185 | Sweden |
| Karolinska University Hospital | Stockholm | S-118 83 | Sweden |
| Norrlands Universitetssjukhus, Umeå, Cancercentrum | Umeå | 90185 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 75185 | Sweden |
| Universitaetsspital Basel | Basel | 4031 | Switzerland |
| Hôpitaux Universit. de Genève Gynécologique - Oncologie | Geneva | 1211 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6004 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich | Zurich | 8008 | Switzerland |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Kaohsiung Medical Uni Chung-Ho Hospital | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Cheng Kung Uni Hospital | Tainan | 704 | Taiwan |
| Veterans General Hospital | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 100 | Taiwan |
| Tri-Service General Hospital, Division of General Surgery | Taipei | 114 | Taiwan |
| Chiang Rai Prachanukraw Hospital | Chiang Rai | 57000 | Thailand |
| Lopburi Cancer Hospital | Lopburi | 15000 | Thailand |
| Buddhachinaraj Phitsanulok Hospital | Phitsanulok | 65000 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Surat Thani Hospital | Surat Thani | 84000 | Thailand |
| Cherkassy Regional Oncological Hospital | Cherkassy | 18009 | Ukraine |
| State Medical Academy | Dnipropetrovsk | 43102 | Ukraine |
| Ivano-Frankivsk Regional Oncology Center | Ivano-Frankivsk | 76018 | Ukraine |
| Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients | Kiev | 03115 | Ukraine |
| Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| Lvov State Regional Oncology Medical & Diagnostic Center | Lviv | 79031 | Ukraine |
| Ternopil State Medical Academy | Ternopil | 46023 | Ukraine |
| Royal Berkshire Hospital | Berkshire | RG1 5AN | United Kingdom |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| Cheltenham General Hospital | Cheltenham | GL53 7AN | United Kingdom |
| Colchester General Hospital | Colchester, Essex | CO4 5JL | United Kingdom |
| University Hospital coventry | Coventry | CV2 2DX | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Royal Devon & Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Ipswich Hospital | Ipswich | IP4 5PD | United Kingdom |
| St James Uni Hospital | Leeds | LS9 7TF | United Kingdom |
| St. Bartholomew'S Hospital | London | EC1A 7BE | United Kingdom |
| UCL Hospital NHS Trust | London | NW1 2PG | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Ctr For Oncolgy | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Mount Vernon Hospital | Northwood | HA6 2RN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Peterborough City Hospital, Edith Cavell Campus | Peterborough | PE3 9GZ | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Royal Preston Hosp | Preston | PR2 9HT | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| Uni Hospital of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Royal Marsden Hosp NHS Fnd | Sutton | SM2 5PT | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber RD, Restuccia E, Im YH, Huang CS, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez HL, Bliss J, Viale G, Bines J, Piccart M; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. J Clin Oncol. 2024 Nov;42(31):3643-3651. doi: 10.1200/JCO.23.02505. Epub 2024 Sep 11. |
| 36681013 | Derived | de Azambuja E, Agostinetto E, Procter M, Eiger D, Ponde N, Guillaume S, Parlier D, Lambertini M, Desmet A, Caballero C, Aguila C, Jerusalem G, Walshe JM, Frank E, Bines J, Loibl S, Piccart-Gebhart M, Ewer MS, Dent S, Plummer C, Suter T; APHINITY Steering Committee and Investigators. Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY trial. ESMO Open. 2023 Feb;8(1):100772. doi: 10.1016/j.esmoop.2022.100772. Epub 2023 Jan 19. |
| 35512402 | Derived | Lambertini M, Fielding S, Loibl S, Janni W, Clark E, Franzoi MA, Fumagalli D, Caballero C, Arecco L, Salomoni S, Ponde NF, Poggio F, Kim HJ, Villarreal-Garza C, Pagani O, Paluch-Shimon S, Ballestrero A, Del Mastro L, Piccart M, Bines J, Partridge AH, de Azambuja E. Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy. J Natl Cancer Inst. 2022 Aug 8;114(8):1117-1126. doi: 10.1093/jnci/djac096. |
| 35313167 | Derived | Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18. |
| 33828257 | Derived | Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7. |
| 33539215 | Derived | Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4. |
| 31924513 | Derived | Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5. |
| 31305270 | Derived | Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808. |
| 30976844 | Derived | Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11. |
| 28581356 | Derived | von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5. |
| FG001 | 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]). |
|
| Received at Least 1 Dose of Pertuzumab | Pertuzumab Safety Population |
|
| Received Any Study Treatment Except for Pertuzumab | Placebo Safety Population |
|
| Entered Follow-Up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants regardless of treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pertuzumab + Trastuzumab + Chemotherapy | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | ITT population | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Nodal Status | The disease status of a participant's lymph nodes (positive or negative and number affected) was one of the study's randomization stratification factors. Nodal status may have taken any of the four categories for participants who enrolled under protocol version A, but only the two categories with positive nodes after protocol version B had been implemented. | Count of Participants | Participants |
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| Adjuvant Chemotherapy Regimen | The type of adjuvant chemotherapy regimen that the investigator chose for each participant's treatment (anthracycline or non-anthracycline containing regimen) was one of the study's randomization stratification factors. | Count of Participants | Participants |
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| Hormone Receptor Status | Central laboratory assessment of the hormone receptor status (estrogen receptor [ER] and progesterone receptor [PgR] positive or negative) of each participant's tumor tissue sample was conducted at screening. The hormone receptor status was one of the study's randomization stratification factors. | Count of Participants | Participants |
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| Protocol Version at Enrollment | The protocol version at enrollment (Version A or B) was one of the study's randomization stratification factors. The amendment from protocol version A (28-June-2011) to version B (20-Nov-2012) was made mainly to adjust for a higher than expected rate of recruitment of node-negative patients. Therefore, the trial sample size was increased from N=3806 to N=4800 and node-negative patients were no longer permitted to enroll. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 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). | ITT population | Posted | Number | percentage of participants | 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) |
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| Secondary | 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 | 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). | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 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. | ITT population | Posted | Number | percentage of participants | 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) |
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| Secondary | 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 | 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. | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants Who Died, First Interim Overall Survival Analysis | Percentage of participants who died due to any cause is reported. | ITT population | Posted | Number | percentage of participants | 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) |
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| Secondary | Percentage of Participants Who Died, Final Overall Survival Analysis | Percentage of participants who died due to any cause is reported. | ITT population | Posted | Number | percentage of participants | Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years) |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 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. | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for death at Year 3. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
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| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence. | ITT population | Posted | Number | percentage of participants | 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) |
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| Secondary | 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 | 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. | ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at 3 years. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence. | ITT population | Posted | Number | percentage of participants | Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) |
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| Secondary | 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 | 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. | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DRFI event at 3 years. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 6, 8, and 10 years |
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| Secondary | Percentage of Participants With Primary Cardiac Event, Primary Analysis | 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. | Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received. | Posted | Number | percentage of participants | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
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| Secondary | Percentage of Participants With Primary Cardiac Event, Final Analysis | 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. | Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received. | Posted | Number | percentage of participants | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
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| Secondary | Percentage of Participants With Secondary Cardiac Event, Primary Analysis | 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). | Safety population | Posted | Number | percentage of participants | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
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| Secondary | Percentage of Participants With Secondary Cardiac Event, Final Analysis | 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). | Safety population | Posted | Number | percentage of participants | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
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| Secondary | Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | 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. | 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. | Posted | Mean | Standard Deviation | percentage of blood pumped out | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) |
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| Secondary | Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | 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. | 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. | Posted | Mean | Standard Deviation | percentage of blood pumped out | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | 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. | ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | 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. | ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | 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. | ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | 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. | ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | 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. | ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | 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. | ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | 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. | ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 |
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| Secondary | Trough Serum Concentration (Cmin) of Pertuzumab | 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. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Cycles 1, 10 and 15 (Cycle length=21 days) |
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| Secondary | Cmin of Trastuzumab | PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | mcg/mL | Cycles 1, 10 and 15 (Cycle length=21 days) |
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| Secondary | Peak Serum Concentration (Cmax) of Pertuzumab | PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | mcg/mL | Cycles 1, 10 and 15 (Cycle length=21 days) |
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| Secondary | Cmax of Trastuzumab | PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | mcg/mL | Cycles 1, 10 and 15 (Cycle length=21 days) |
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| Primary | 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 | 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. | ITT population | Posted | Number | percentage of participants | 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) |
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| Primary | 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 | 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. | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (excluding SPNBC) at 3 years. | Posted | Number | 95% Confidence Interval | Estimate of percentage of participants | 3 years |
|
From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years)
All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 [2340 pertuzumab arm + 24 placebo arm who received any pertuzumab]; Placebo: N=2405 [2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pertuzumab + Trastuzumab + Chemotherapy | 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). | 205 | 2,400 | 792 | 2,364 | 2,353 | 2,364 |
| EG001 | 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). | 247 | 2,404 | 686 | 2,405 | 2,374 | 2,405 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| IDIOPATHIC CYTOPENIA OF UNDETERMINED SIGNIFICANCE | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| MICROANGIOPATHIC HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| MYELOSUPPRESSION | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| AORTIC VALVE DISEASE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ARRHYTHMIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIAL THROMBOSIS | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CARDIOMYOPATHY | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CORONARY ARTERY THROMBOSIS | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| DILATED CARDIOMYOPATHY | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| EXTRASYSTOLES | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| HYPERTENSIVE HEART DISEASE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| METABOLIC CARDIOMYOPATHY | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| MITRAL VALVE DISEASE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| SINUS NODE DYSFUNCTION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| TACHYCARDIA PAROXYSMAL | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| VENTRICULAR ARRHYTHMIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| VENTRICULAR HYPOKINESIA | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
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| CONGENITAL APLASIA | Congenital, familial and genetic disorders | MedDRA version 27.1 | Systematic Assessment |
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| PYLORIC STENOSIS | Congenital, familial and genetic disorders | MedDRA version 27.1 | Systematic Assessment |
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| EXTERNAL EAR INFLAMMATION | Ear and labyrinth disorders | MedDRA version 27.1 | Systematic Assessment |
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| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA version 27.1 | Systematic Assessment |
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| TYMPANIC MEMBRANE PERFORATION | Ear and labyrinth disorders | MedDRA version 27.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA version 27.1 | Systematic Assessment |
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| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA version 27.1 | Systematic Assessment |
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| GOITRE | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
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| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
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| THYROID DISORDER | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
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| OPTIC NERVE DISORDER | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
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| PAPILLOEDEMA | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
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| VISUAL ACUITY REDUCED | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
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| VISUAL FIELD DEFECT | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ANAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DUODENAL PERFORATION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DUODENAL ULCER | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| DUODENAL ULCER PERFORATION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| FEMORAL HERNIA STRANGULATED | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROINTESTINAL PAIN | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROINTESTINAL TOXICITY | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INTRA-ABDOMINAL HAEMATOMA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| INTUSSUSCEPTION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| NEUTROPENIC COLITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| OEDEMA MOUTH | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| OESOPHAGEAL PAIN | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ORAL PAIN | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| PROCTITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| SUBILEUS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| CYST | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| DEVICE RELATED THROMBOSIS | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| GENERALISED OEDEMA | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| MASS | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| NECROSIS | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 27.1 | Systematic Assessment |
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| BILIARY COLIC | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHOLANGITIS | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
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| ANAPHYLACTIC SHOCK | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
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| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
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| ABDOMINAL ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| ABDOMINAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| ABSCESS ORAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| ACUTE HEPATITIS B | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ANORECTAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST CELLULITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| CHRONIC SINUSITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| CLOSTRIDIUM COLITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DISSEMINATED TUBERCULOSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| DIVERTICULITIS INTESTINAL PERFORATED | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| HEPATITIS B REACTIVATION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| HERPES ZOSTER DISSEMINATED | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| INFECTED LYMPHOCELE | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| INFECTED SEROMA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| LARYNGOPHARYNGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| LYMPHANGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| MASTITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PERIODONTITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PHLEBITIS INFECTIVE | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PLEURAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA PSEUDOMONAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PSEUDOMONAL BACTERAEMIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| RECTAL ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SALPINGO-OOPHORITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SERRATIA INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| STREPTOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| VULVAL ABSCESS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| AVULSION FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| FRACTURED SACRUM | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| GRAFT THROMBOSIS | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| ILIUM FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMOCONIOSIS | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMOTHORAX TRAUMATIC | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| PULMONARY RADIATION INJURY | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| SHOULDER FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| BLOOD GLUCOSE FLUCTUATION | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SJOGREN'S SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ANGIOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| APPENDIX CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| B PRECURSOR TYPE ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BENIGN BREAST NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BENIGN NEOPLASM OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BILE DUCT ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BONE GIANT CELL TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST ANGIOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| BRONCHIAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CARDIAC MYXOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CHONDROSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CHRONIC LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CLEAR CELL RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| CONJUNCTIVAL MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| DERMATOFIBROSARCOMA PROTUBERANS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| DIFFUSE LARGE B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ENDOMETRIAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ESSENTIAL THROMBOCYTHAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| FOLLICULAR LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| GANGLIONEUROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTRIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTROINTESTINAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| GLIOBLASTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| INTRADUCTAL PROLIFERATIVE BREAST LESION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LENTIGO MALIGNA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| LYMPHOCYTIC LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM OF RENAL PELVIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MALIGNANT PERITONEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| METASTATIC UTERINE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MONOCLONAL GAMMOPATHY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEOPLASM OF ORBIT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEURILEMMOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA OF THE SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROENDOCRINE TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| OVARIAN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| OVARIAN EPITHELIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PARATHYROID TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PELVIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| RETINAL MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SALIVARY GLAND CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SECOND PRIMARY MALIGNANCY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SMALL INTESTINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SMALL INTESTINE LEIOMYOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SOFT TISSUE SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE TONGUE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| UTERINE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| VULVAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| AUTONOMIC NERVOUS SYSTEM IMBALANCE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HEAD TITUBATION | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INTERCOSTAL NEURALGIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MIGRAINE WITH AURA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NEURALGIC AMYOTROPHY | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROTOXICITY | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PSYCHOGENIC SEIZURE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SUNCT SYNDROME | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| THALAMIC INFARCTION | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA version 27.1 | Systematic Assessment |
| |
| DEVICE BREAKAGE | Product Issues | MedDRA version 27.1 | Systematic Assessment |
| |
| DEVICE DISLOCATION | Product Issues | MedDRA version 27.1 | Systematic Assessment |
| |
| DEVICE EXTRUSION | Product Issues | MedDRA version 27.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DELUSIONAL DISORDER, UNSPECIFIED TYPE | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOMANIA | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MENTAL DISORDER | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PERSISTENT DEPRESSIVE DISORDER | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PERSONALITY CHANGE | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| REACTIVE PSYCHOSIS | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ABNORMAL UTERINE BLEEDING | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST INFLAMMATION | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CERVICAL POLYP | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HEAVY MENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PELVIC CYST | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NASAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NASAL POLYPS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ACUTE FEBRILE NEUTROPHILIC DERMATOSIS | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DERMATITIS EXFOLIATIVE GENERALISED | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| TOXIC SKIN ERUPTION | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST TUMOUR EXCISION | Surgical and medical procedures | MedDRA version 27.1 | Systematic Assessment |
| |
| HOSPITALISATION | Surgical and medical procedures | MedDRA version 27.1 | Systematic Assessment |
| |
| SKIN NEOPLASM EXCISION | Surgical and medical procedures | MedDRA version 27.1 | Systematic Assessment |
| |
| AXILLARY VEIN THROMBOSIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| EMBOLISM VENOUS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| D015251 | Epirubicin |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| Other |
|
| Not reported |
|
| 0 Positive Nodes and Tumor >1 cm |
|
| 1 to 3 Positive Nodes |
|
| ≥4 Positive Nodes |
|
| Non-anthracycline containing regimen |
|
| Positive (ER and/or PgR positive) |
|
| Protocol Version B |
|
| 8 Years |
|
|
| 10 Years |
|
|
| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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|
| 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). |
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| OG001 | 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). |
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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). |
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| OG001 | 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). |
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| OG001 | 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). |
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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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 |
| 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). |
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| OG001 |
| 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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| OG001 | 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). |
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