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97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Overall Number of Participants Analyzed: 37 secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Measure Type: Count of Participants secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
97e3b0d7-3320-4eb5-bc42-5031db87692e
primary trial: Unit of Measure: Participants 2 5.4% secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.
0
83251670-803e-4fec-a5cf-50f052932752
Percentage of Progression Free Participants After 16 Weeks of Treatment All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD. All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Time frame: 16 weeks All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Arm/Group Title: Afatinib 50 mg With Letrozole All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Overall Number of Participants Analyzed: 7 All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Measure Type: Number All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Unit of Measure: Percentage of participants 28.57 (3.67 to 70.96) All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Arm/Group Title: Afatinib 40 mg With Letrozole All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Arm/Group Description: Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression. All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Overall Number of Participants Analyzed: 13 All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Measure Type: Number All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
83251670-803e-4fec-a5cf-50f052932752
Unit of Measure: Percentage of participants 0.00 (0.00 to 24.71) All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.
0
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Total: 146/573 (25.48%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Anaemia 4/573 (0.70%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Disseminated intravascular coagulation 0/573 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Neutropenia 1/573 (0.17%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Thrombocytopenia 0/573 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Acute coronary syndrome 1/573 (0.17%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Angina pectoris 1/573 (0.17%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Atrial fibrillation 2/573 (0.35%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Atrial flutter 0/573 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Cardiac arrest 1/573 (0.17%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Cardiac failure 0/573 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Total: 101/570 (17.72%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Anaemia 3/570 (0.53%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Disseminated intravascular coagulation 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Neutropenia 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Thrombocytopenia 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Acute coronary syndrome 0/570 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Angina pectoris 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Atrial fibrillation 0/570 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Atrial flutter 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Cardiac arrest 0/570 (0.00%) 1 patient in the primary trial had an abrupt loss of heart function.
1
efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de
Cardiac failure 1/570 (0.18%) 1 patient in the primary trial had an abrupt loss of heart function.
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Total: 7/7 (100.00%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Total: 7/7 (100.00%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Total: 7/7 (100.00%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Total: 7/7 (100.00%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Total: 7/7 (100.00%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Febrile neutropenia 3/7 (42.86%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Febrile neutropenia 3/7 (42.86%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Febrile neutropenia 3/7 (42.86%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Febrile neutropenia 3/7 (42.86%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Febrile neutropenia 3/7 (42.86%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Cardiac failure 1/7 (14.29%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Cardiac failure 1/7 (14.29%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Cardiac failure 1/7 (14.29%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Cardiac failure 1/7 (14.29%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Cardiac failure 1/7 (14.29%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Neutrophil count decreased 1/7 (14.29%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Neutrophil count decreased 1/7 (14.29%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Neutrophil count decreased 1/7 (14.29%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Neutrophil count decreased 1/7 (14.29%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Neutrophil count decreased 1/7 (14.29%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Muscular weakness 1/7 (14.29%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Muscular weakness 1/7 (14.29%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Muscular weakness 1/7 (14.29%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Muscular weakness 1/7 (14.29%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Muscular weakness 1/7 (14.29%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a
primary trial: Epistaxis 1/7 (14.29%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).
1