Trial Outcomes & Findings for Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer (NCT NCT01220128)

NCT ID: NCT01220128

Last Updated: 2021-05-25

Results Overview

Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at \< 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo. - A Grade 2 or higher allergic reaction occurring within 24 hours following the administration. - A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration. - A decrease in renal function at the time of administration that was considered as related or possibly related.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)
• Results posted on: 2021-05-25

Participant Flow

Out of the 66 enrolled patients, 6 patients did not receive study product doses and were hence excluded prior to study start.

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Cohort A-GSK2302024A Group This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.	Cohort A-Placebo Group This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort B-GSK2302024A Group This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-Placebo Group This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Study STARTED	15	7	9	6	11	4	8
Overall Study COMPLETED	11	6	6	6	11	4	3
Overall Study NOT COMPLETED	4	1	3	0	0	0	5

Reasons for withdrawal

Measure	Cohort A-GSK2302024A Group This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.	Cohort A-Placebo Group This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort B-GSK2302024A Group This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-Placebo Group This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Study Progressive disease	0	0	2	0	0	0	0
Overall Study Sponsor study termination	0	1	0	0	0	0	1
Overall Study Adverse event, serious fatal	2	0	0	0	0	0	1
Overall Study Adverse event, non-fatal	1	0	0	0	0	0	3
Overall Study Other	0	0	1	0	0	0	0
Overall Study Consent withdrawn by subject	1	0	0	0	0	0	0

Baseline Characteristics

Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

Baseline characteristics by cohort

Measure	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Total n=60 Participants Total of all reporting groups
Age, Continuous	69.3 Years STANDARD_DEVIATION 10.4 • n=5 Participants	70.9 Years STANDARD_DEVIATION 7.1 • n=7 Participants	49.3 Years STANDARD_DEVIATION 15.6 • n=5 Participants	60.7 Years STANDARD_DEVIATION 9.8 • n=4 Participants	52.9 Years STANDARD_DEVIATION 10.6 • n=21 Participants	53.3 Years STANDARD_DEVIATION 6.2 • n=10 Participants	49.6 Years STANDARD_DEVIATION 8.7 • n=115 Participants	58.9 Years STANDARD_DEVIATION 10.2 • n=6 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants	4 Participants n=10 Participants	8 Participants n=115 Participants	60 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Severe toxicity was defined as follows: - A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo - A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks. - A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo. - A Grade 2 or higher allergic reaction occurring within 24 hours following the administration. - A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration. - A decrease in renal function at the time of administration that was considered as related or possibly related.

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Severe Toxicities	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At post-GSK2302024A/placebo Dose 4 (Week 13)

Population: According-to-Protocol (ATP) Population for immunogenicity included all eligible patients who did not report major protocol deviation, who had at least received the first 4 doses of study product and provided a valid result for immunogenicity measurement within the 4 weeks following Dose 4.

For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-administration antibody concentration.

Outcome measures

Measure	Cohort B-GSK2302024A Group n=8 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=10 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=4 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=3 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=3 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response	0 Subjects	0 Subjects	6 Subjects	10 Subjects	0 Subjects	0 Subjects	2 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Patients With Adverse Events (AEs)	9 Subjects	6 Subjects	11 Subjects	15 Subjects	5 Subjects	4 Subjects	7 Subjects

PRIMARY outcome

Timeframe: From Week 0 to Week 26/32 (period starting from GSK2302024A/placebo treatment allocation and ending with the concluding Visit i.e.: Week 26 for patients receiving 6 injections and Week 32 for patients receiving 8 injections)

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Serious Adverse Events SAE(s)	4 Subjects	2 Subjects	5 Subjects	3 Subjects	0 Subjects	1 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade 0	8 Subjects	4 Subjects	6 Subjects	12 Subjects	5 Subjects	2 Subjects	1 Subjects
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade 1	1 Subjects	2 Subjects	5 Subjects	2 Subjects	1 Subjects	2 Subjects	2 Subjects
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	5 Subjects
Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade 0	8 Subjects	6 Subjects	7 Subjects	10 Subjects	5 Subjects	3 Subjects	1 Subjects
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	0 Subjects	4 Subjects	5 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	4 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade 0	1 Subjects	0 Subjects	0 Subjects	12 Subjects	7 Subjects	0 Subjects	2 Subjects
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade 1	7 Subjects	4 Subjects	7 Subjects	2 Subjects	0 Subjects	3 Subjects	2 Subjects
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade 3	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Anemia, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade 0	8 Subjects	6 Subjects	7 Subjects	12 Subjects	4 Subjects	1 Subjects	2 Subjects
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	0 Subjects	4 Subjects	3 Subjects	2 Subjects	3 Subjects	1 Subjects
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	6 Subjects	11 Subjects	15 Subjects	5 Subjects	2 Subjects	3 Subjects
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade 0	8 Subjects	5 Subjects	10 Subjects	11 Subjects	4 Subjects	3 Subjects	3 Subjects
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	1 Subjects	1 Subjects	4 Subjects	2 Subjects	1 Subjects	0 Subjects
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	4 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	6 Subjects	11 Subjects	15 Subjects	6 Subjects	4 Subjects	4 Subjects
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade 0	8 Subjects	6 Subjects	11 Subjects	14 Subjects	3 Subjects	4 Subjects	3 Subjects
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	0 Subjects	0 Subjects	1 Subjects	3 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	3 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade 0	7 Subjects	6 Subjects	10 Subjects	15 Subjects	5 Subjects	4 Subjects	3 Subjects
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade 2	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	6 Subjects	10 Subjects	14 Subjects	4 Subjects	4 Subjects	3 Subjects
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	0 Subjects	0 Subjects	1 Subjects	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	5 Subjects	9 Subjects	13 Subjects	6 Subjects	3 Subjects	3 Subjects
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	1 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade 0	5 Subjects	4 Subjects	10 Subjects	12 Subjects	6 Subjects	3 Subjects	3 Subjects
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade 2	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade 1	3 Subjects	1 Subjects	1 Subjects	3 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	6 Subjects	10 Subjects	15 Subjects	6 Subjects	4 Subjects	3 Subjects
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade 2	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects
Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and post 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade 0	5 Subjects	6 Subjects	11 Subjects	15 Subjects	6 Subjects	4 Subjects	3 Subjects
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	5 Subjects
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade 1	4 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade 3	1 Subjects	2 Subjects	1 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade 0	0 Subjects	0 Subjects	2 Subjects	9 Subjects	4 Subjects	1 Subjects	1 Subjects
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade 1	3 Subjects	2 Subjects	3 Subjects	5 Subjects	2 Subjects	1 Subjects	1 Subjects
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade 2	5 Subjects	2 Subjects	5 Subjects	1 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade 0	9 Subjects	6 Subjects	11 Subjects	15 Subjects	7 Subjects	4 Subjects	4 Subjects
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade 0	7 Subjects	5 Subjects	10 Subjects	12 Subjects	6 Subjects	3 Subjects	0 Subjects
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	1 Subjects	1 Subjects	3 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade 2	1 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade 0	8 Subjects	5 Subjects	5 Subjects	14 Subjects	6 Subjects	2 Subjects	2 Subjects
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade 1	1 Subjects	1 Subjects	5 Subjects	1 Subjects	1 Subjects	2 Subjects	2 Subjects
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade 2	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=6 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=3 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=7 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=13 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade 2	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade 0	6 Subjects	3 Subjects	7 Subjects	13 Subjects	7 Subjects	2 Subjects	0 Subjects
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade 1	2 Subjects	2 Subjects	4 Subjects	2 Subjects	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade 3	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade Grade Unknown	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s) Grade 1	0 Subjects	0 Subjects	0 Subjects	6 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s) Grade 2	6 Subjects	0 Subjects	4 Subjects	6 Subjects	4 Subjects	3 Subjects	2 Subjects
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s) Grade 3	0 Subjects	5 Subjects	3 Subjects	3 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s) Grade 4	2 Subjects	1 Subjects	4 Subjects	0 Subjects	0 Subjects	1 Subjects	4 Subjects
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s) Grade 5	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported Any AE(s)	9 Subjects	6 Subjects	11 Subjects	15 Subjects	5 Subjects	4 Subjects	7 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s) Grade 5	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s)	3 Subjects	0 Subjects	7 Subjects	12 Subjects	2 Subjects	1 Subjects	6 Subjects
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s) Grade 1	0 Subjects	0 Subjects	5 Subjects	7 Subjects	2 Subjects	0 Subjects	2 Subjects
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s) Grade 2	3 Subjects	0 Subjects	1 Subjects	4 Subjects	0 Subjects	1 Subjects	4 Subjects
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s) Grade 3	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related AE(s) Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s)	4 Subjects	2 Subjects	5 Subjects	3 Subjects	0 Subjects	1 Subjects	5 Subjects
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s) Grade 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s) Grade 2	1 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s) Grade 5	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s) Grade 3	0 Subjects	1 Subjects	1 Subjects	2 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported Any SAE(s) Grade 4	2 Subjects	1 Subjects	4 Subjects	0 Subjects	0 Subjects	1 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the treatment period and up to 30 days post last administration

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009. Grades refer to the severity of the AE: mild (grade 1), moderate (grade 2), severe or medically significant (grade 3), life-threatening (grade 4) and death (grade 5).

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=15 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=7 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s) Grade 1	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s) Grade 2	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s) Grade 3	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s) Grade 4	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s) Grade 5	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported Any related SAE(s)	0 Subjects	0 Subjects	1 Subjects	1 Subjects	0 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the treatment period, up to Week 26/32

Population: The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.

The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.

Outcome measures

Measure	Cohort B-GSK2302024A Group n=9 Participants This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 Participants This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort A-GSK2302024A Group n=13 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule	Cohort A-Placebo Group n=6 Participants This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort C-Placebo Group n=4 Participants This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=4 Participants This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Number of Subjects With Breast Cancer Pathological Response Partial respose	5 Subjects	3 Subjects	3 Subjects	4 Subjects	3 Subjects	1 Subjects	3 Subjects
Number of Subjects With Breast Cancer Pathological Response Complete response	0 Subjects	2 Subjects	6 Subjects	0 Subjects	0 Subjects	3 Subjects	1 Subjects

Adverse Events

Cohort A-GSK2302024A Group

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort A-Placebo Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort B-GSK2302024A Group

Serious events: 4 serious events

Other events: 9 other events

Deaths: 1 deaths

Cohort B-Placebo Group

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort C-GSK2302024A Group

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort C-Placebo Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort D-GSK2302024A-D14 Group

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A-GSK2302024A Group n=15 participants at risk This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.	Cohort A-Placebo Group n=7 participants at risk This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort B-GSK2302024A Group n=9 participants at risk This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 participants at risk This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 participants at risk This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-Placebo Group n=4 participants at risk This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 participants at risk This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	6.7% 1/15 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Neutropenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	16.7% 1/6 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	36.4% 4/11 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	37.5% 3/8 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	16.7% 1/6 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	9.1% 1/11 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 1/4 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Leukopenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	9.1% 1/11 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	12.5% 1/8 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Ear and labyrinth disorders Vestibular disorder	6.7% 1/15 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Death	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Haemorrhoidal haemorrhage	6.7% 1/15 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Nausea	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	9.1% 1/11 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Stomatitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	12.5% 1/8 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Vomiting	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	9.1% 1/11 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Hepatobiliary disorders Cholecystitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	12.5% 1/8 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	6.7% 1/15 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	9.1% 1/11 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).

Other adverse events

Measure	Cohort A-GSK2302024A Group n=15 participants at risk This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.	Cohort A-Placebo Group n=7 participants at risk This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, according to the treatment schedule.	Cohort B-GSK2302024A Group n=9 participants at risk This group included breast cancer patients who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel, according to the treatment schedule.	Cohort B-Placebo Group n=6 participants at risk This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-GSK2302024A Group n=11 participants at risk This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.	Cohort C-Placebo Group n=4 participants at risk This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule	Cohort D-GSK2302024A-D14 Group n=8 participants at risk This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	66.7% 6/9 • Number of events 6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	72.7% 8/11 • Number of events 8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 2/4 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	37.5% 3/8 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Vascular disorders Hot flush	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Vascular disorders Flushing	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Fatigue	20.0% 3/15 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	88.9% 8/9 • Number of events 8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	66.7% 4/6 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	63.6% 7/11 • Number of events 7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	100.0% 4/4 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site pain	26.7% 4/15 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	36.4% 4/11 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 4/8 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site erythema	33.3% 5/15 • Number of events 5 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Mucosal inflammation	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 2/4 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site reaction	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site swelling	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Oedema peripheral	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Chills	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site discomfort	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Psychiatric disorders Insomnia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Investigations Weight decreased	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Cardiac disorders Palpitations	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Cardiac disorders Sinus tachycardia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Neutropenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	36.4% 4/11 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	37.5% 3/8 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Anaemia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	36.4% 4/11 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Leukopenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 3/6 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Nervous system disorders Headache	33.3% 5/15 • Number of events 5 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	11.1% 1/9 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	45.5% 5/11 • Number of events 5 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 2/4 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Nervous system disorders Dysgeusia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 3/6 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Nervous system disorders Paraesthesia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Nervous system disorders Neuropathy peripheral	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Stomatitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Constipation	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	36.4% 4/11 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Vomiting	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	44.4% 4/9 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Renal and urinary disorders Pollakiuria	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	100.0% 9/9 • Number of events 9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	83.3% 5/6 • Number of events 5 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	72.7% 8/11 • Number of events 8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	75.0% 3/4 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	37.5% 3/8 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 2/4 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 3/15 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	28.6% 2/7 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	50.0% 2/4 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Myalgia	26.7% 4/15 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	44.4% 4/9 • Number of events 4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	25.0% 2/8 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Bone pain	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 3/9 • Number of events 3 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	27.3% 3/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Metabolism and nutrition disorders Decreased appetite	13.3% 2/15 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Infections and infestations Conjunctivitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Infections and infestations Gingivitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	22.2% 2/9 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Infections and infestations Nasopharyngitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	33.3% 2/6 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Infections and infestations Pharyngitis	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/7 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	18.2% 2/11 • Number of events 2 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
General disorders Injection site haematoma	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Infections and infestations Influenza	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	12.5% 1/8 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/15 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	14.3% 1/7 • Number of events 1 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/9 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/6 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/11 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/4 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).	0.00% 0/8 • AEs were reported during the treatment period and up to 30 days post last administration. SAEs during the entire study period (Week 0 to Week 26/32).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER