Trial Outcomes & Findings for Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy (NCT NCT01051063)

Last Updated: 2018-11-29

Results Overview

Severe toxicities (as classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related: * Grade 4 toxicity (exception: study product-related or possibly study product-related Grade 4 fatigue - including lethargy, asthenia, and malaise - had to have a duration of at least 48 hours to be taken into account). * Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration). * Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition. * Decrease in renal function, with a calculated creatinine clearance \< 40 mL/min. * Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

During the entire study (from Month 0 to Month 49)

Results posted on

2018-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Complete Remission Group Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Overall Study STARTED	12	5
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Complete Remission Group Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Overall Study Death	2	2
Overall Study Withdrawal by Subject	1	1
Overall Study Termination of the study	5	0
Overall Study Moved from the study site area	1	0
Overall Study Other	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Complete Remission Group n=12 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group n=5 Participants Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Total n=17 Participants Total of all reporting groups
Age, Continuous	67.2 Years STANDARD_DEVIATION 8.3 • n=5 Participants	64.2 Years STANDARD_DEVIATION 8.5 • n=7 Participants	66.3 Years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the entire study (from Month 0 to Month 49)

Population: The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=12 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group n=5 Participants Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Patients With Severe Toxicities	1 Participants	0 Participants

PRIMARY outcome

Timeframe: During the entire study (from Month 0 to Month 49)

Population: The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.

CR = having \< 5% blasts in aspirate sample with marrow spicules and with a count of ≥ 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease; different phenotype (by flow cytometry) to the pre-treatment specimen; absolute neutrophil count \> 1000/mm3; platelet count ≥ 100 000/mm3 and being independent of red blood cell (RBC) transfusions. PR = a decrease of ≤ 50% in the % of blasts in bone marrow aspirate compared to Visit 4; being independent of RBC transfusions and the absolute neutrophil ≥ 1000/mm3 and platelet counts and ≥ 100 000/mm3. SD = no sufficient criteria for CR, a PR or Progressive disease (PD = Reappearance of leukemic blasts in the peripheral blood; Reappearance/development of cytologically proven extramedullary disease, Appearance of new dysplastic changes, or in a bone marrow aspirate sample (with marrow spicules and with a count of ≥200 nucleated cells) of ≥5% blasts; or, in case of early progression, a higher blast % than at Visit 4).

Outcome measures

Outcome measures
Measure	Complete Remission Group n=12 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group n=5 Participants Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) CR	5 Participants	0 Participants
Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) SD	6 Participants	1 Participants
Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) PD	1 Participants	1 Participants
Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) PR	0 Participants	3 Participants

SECONDARY outcome

Timeframe: At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4

Population: The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.

Seropositivity rate was defined as the number of patients with anti-WT1 antibody concentrations greater than or equal to (≥) 9 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Anti-WT1 Seropositivity Rate Anti-WT1 PRE	0 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 2, Week 5	1 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 4, Week 9	10 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 6, Week 13	12 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 6, Week 15	12 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 8, Week 21	9 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 12, Week 32	6 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 13, Week 40	5 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 16, Week 54	5 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 17, Visit 21+3 months, Month 18	3 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 18, Visit 22+3 months, Month 21	3 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 19, Visit 23+3 months, Month 24	2 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 20, Visit 24+6 months, Month 30	2 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 21, Visit 25+6 months, Month 36	1 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 22, Visit 26+6 months, Month 42	1 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Last dose+30 days, Month 49	5 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-Follow-up Visit 1	1 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-Follow-up Visit 2	1 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-dose 16, Visit 19+3 months, Month 15	3 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-Follow-up Visit 3	0 Participants	—
Anti-WT1 Seropositivity Rate Anti-WT1 Post-Follow-up Visit 4	0 Participants	—

SECONDARY outcome

Timeframe: At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4

Antibody concentrations were expressed as geometric mean concentrations, measured in ELISA units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 2, Week 5	5.4 EU/mL Interval 3.7 to 7.9	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 4, Week 9	52.0 EU/mL Interval 18.6 to 145.4	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 6, Week 13	123.8 EU/mL Interval 50.0 to 306.5	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 6, Week 15	138.3 EU/mL Interval 65.3 to 292.8	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 8, Week 21	105.0 EU/mL Interval 35.6 to 309.7	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 12, Week 32	136.4 EU/mL Interval 29.4 to 632.2	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 13, Week 40	113.0 EU/mL Interval 21.1 to 603.4	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 16, Week 54	125.3 EU/mL Interval 19.7 to 796.3	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 16, Visit 19+3 months, Month 15	157.1 EU/mL Interval 34.8 to 709.5	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 17, Visit 21+3 months, Month 18	51.8 EU/mL Interval 3.5 to 774.7	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 21, Visit 25+6 months, Month 36	122.0 EU/mL Only one subject was analyzed, therefore the lower and upper limits of the 95% CI could not be computed.	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 22, Visit 26+6 months, Month 42	115.0 EU/mL Only one subject was analyzed, therefore the lower and upper limits of the 95% CI could not be computed.	—
Anti-WT1 Antibody Concentrations Anti-WT1 Last dose+30 days, Month 49	32.2 EU/mL Interval 8.3 to 124.4	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-Follow-up Visit 1	7.0 EU/mL Interval 0.0 to 2058.0	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-Follow-up Visit 2	7.9 EU/mL Interval 0.0 to 10745.2	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-Follow-up Visit 3	4.5 EU/mL Only one subject was analyzed, therefore the lower and upper limits of the 95% CI could not be computed.	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-Follow-up Visit 4	4.5 EU/mL Only one subject was analyzed, therefore the lower and upper limits of the 95% CI could not be computed.	—
Anti-WT1 Antibody Concentrations Anti-WT1 PRE	4.5 EU/mL Interval 4.5 to 4.5	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 18, Visit 22+3 months, Month 21	106.6 EU/mL Interval 39.9 to 284.7	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 19, Visit 23+3 months, Month 24	131.6 EU/mL Interval 0.2 to 101198.4	—
Anti-WT1 Antibody Concentrations Anti-WT1 Post-dose 20, Visit 24+6 months, Month 30	102.9 EU/mL Interval 7.8 to 1352.2	—

SECONDARY outcome

Timeframe: At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4

The anti-WT1 antibody response was defined as: For initially seronegative patients, post-vaccination antibody concentration ≥ 9 EU/mL; For initially seropositive patients, post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Anti-WT1 Antibody Response Anti-WT1 Post-dose 2, Week 5	1 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 4, Week 9	10 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 6, Week 13	12 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 6, Week 15	12 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 8, Week 21	9 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 12, Week 32	6 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 13, Week 40	5 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 16, Week 54	5 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 16, Visit 19+3 months, Month 15	3 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 17, Visit 21+3 months, Month 18	3 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 18, Visit 22+3 months, Month 21	3 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 19, Visit 23+3 months, Month 24	2 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 20, Visit 24+6 months, Month 30	2 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-Follow-up Visit 1	1 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-Follow-up Visit 2	1 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-Follow-up Visit 3	0 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-Follow-up Visit 4	0 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post-dose 21, Visit 25+6 months, Month 36	1 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Post dose 22, Visit 26+6 months, Month 42	1 Participants	—
Anti-WT1 Antibody Response Anti-WT1 Last dose+30 days, Month 49	5 Participants	—

SECONDARY outcome

Timeframe: Starting with the first administration of study treatment and ending 30 days after the last study treatment administration

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Related = AE assessed by the investigator as causally related to the study treatment.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Subjects With Any and Related Unsolicited Adverse Events (AEs) Any AE(s)	15 Participants	—
Number of Subjects With Any and Related Unsolicited Adverse Events (AEs) Related AE(s)	10 Participants	—

SECONDARY outcome

Timeframe: During the entire study (from Month 0 to Month 49)

Population: The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.

Study treatment failure was defined as withdrawal from investigational product because of disease progression or death. Among the characteristics evaluated were: Progression, Death in absence of Relapse, Relapse or progression or Death (Progression Free Survival event), Death \[An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE\], Autopsy performed and Cause of death.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=12 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group n=5 Participants Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Subjects With Study Treatment Failure Progression - yes	6 Participants	5 Participants
Number of Subjects With Study Treatment Failure Progression - no	6 Participants	0 Participants
Number of Subjects With Study Treatment Failure Death in absence of Relapse - yes	0 Participants	0 Participants
Number of Subjects With Study Treatment Failure Death in absence of Relapse - no	12 Participants	5 Participants
Number of Subjects With Study Treatment Failure Progression Free Survival event - yes	6 Participants	5 Participants
Number of Subjects With Study Treatment Failure Progression Free Survival event - no	6 Participants	0 Participants
Number of Subjects With Study Treatment Failure Death - yes	4 Participants	2 Participants
Number of Subjects With Study Treatment Failure Death - no	8 Participants	3 Participants
Number of Subjects With Study Treatment Failure Autopsy performed - yes	0 Participants	0 Participants
Number of Subjects With Study Treatment Failure Autopsy performed - no	4 Participants	1 Participants
Number of Subjects With Study Treatment Failure Cause of death, Disease under study (AML)	4 Participants	2 Participants
Number of Subjects With Study Treatment Failure Autopsy performed - unknown	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the entire study (from Month 0 to Month 49)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as causally related to the study treatment. An event that 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 did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Subjects With Any or Related Serious Adverse Events (SAEs) Related SAE(s)	1 Participants	—
Number of Subjects With Any or Related Serious Adverse Events (SAEs) Any SAE(s)	7 Participants	—

SECONDARY outcome

Timeframe: During the entire study (Month 0 to Month 49)

Haematological and biochemical parameters assessed were Alanine aminotransferase, Aspartate aminotransferase, Alkaline Phosphatase, Bilirubin, Creatinine, Gamma-glutamyl transpeptidase, Hemoglobin, Hypercalcemia, Hyperkalemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypokalemia, Hyponatremia, Leukocytes, Lymphopenia, Neutrophils, Platelets and Proteinuria. Parameters were assessed as per the Common Terminology Criteria for adverse events (CTCAE), where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe but not life-threatening and Grade 4 = life-threatening.

Outcome measures

Outcome measures
Measure	Complete Remission Group n=17 Participants Adult patients in complete remission with incomplete blood count recovery post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.	Partial Remission Group Adult patients in partial remission post-induction chemotherapy, who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Grade 0	10 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Grade 1	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Grade 2	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Aspartate aminotransferase, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Grade 0	15 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Grade 1	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alkaline Phosphatase, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Grade 2	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Grade 0	8 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Alanine aminotransferase, Grade 1	7 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Grade 0	15 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Grade 1	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Grade 2	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Grade 0	13 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Grade 1	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Grade 2	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Creatinine, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Grade 0	9 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Grade 1	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Grade 2	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Gamma-glutamyl transpeptidase, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Grade 0	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Grade 1	5 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Grade 2	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Grade 3	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Grade 4	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hemoglobin, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Grade 0	14 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Grade 0	17 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Grade 1	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyperkalemia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Grade 0	17 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Grade 1	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypernatremia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Grade 0	15 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Grade 1	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Grade 3	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Grade 0	14 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Grade 1	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Grade 0	13 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Grade 1	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Grade 1	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Grade 0	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Grade 1	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Grade 1	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Bilirubin, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypercalcemia, Grade 1	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypoalbuminemia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Grade 0	12 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Grade 1	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Grade 2	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypocalcemia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Grade 3	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hypokalemia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Hyponatremia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Grade 0	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Grade 2	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Grade 3	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Grade 4	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Leukocytes, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Grade 2	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Grade 3	4 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Grade 4	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Lymphopenia, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Grade 0	5 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Grade 1	2 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Grade 2	3 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Grade 3	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Grade 4	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Neutrophils, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Grade 0	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Grade 1	5 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Grade 2	1 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Grade 3	5 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Grade 4	6 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Platelets, Unknown	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Grade 0	12 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Grade 2	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Grade 3	0 Participants	—
Number of Patients With Abnormal Hematological and Biochemical Parameters Proteinuria, Unknown	1 Participants	—

Adverse Events

Total Treated Group

Serious events: 7 serious events

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Total Treated Group n=17 participants at risk All adult patients (who underwent either partial or complete remission after induction chemotherapy) who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Blood and lymphatic system disorders Leukocytosis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Neutropenia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Pyrexia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Bronchitis	5.9% 1/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Diverticulitis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Pneumonia	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Metabolism and nutrition disorders Hypercalcaemia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Vascular disorders Hypertensive crisis	5.9% 1/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Vascular disorders Vascular stenosis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).

Other adverse events

Other adverse events
Measure	Total Treated Group n=17 participants at risk All adult patients (who underwent either partial or complete remission after induction chemotherapy) who received the GSK2130579A study product, administered sequentially, as follows: Cycle 1: 6 doses, each given at 2-week intervals; Cycle 2: 6 doses, each given at 3-week intervals; Cycle 3: 4 doses, each given at 6-week intervals; Cycle 4: 4 doses, each given at 3-month intervals, followed by 4 doses each given at 6-month intervals.
Skin and subcutaneous tissue disorders Ecchymosis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Anaemia	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Leukocytosis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Lymphopenia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Neutropenia	11.8% 2/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Blood and lymphatic system disorders Thrombocytopenia	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Cardiac disorders Arrhythmia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Ear and labyrinth disorders Vertigo	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Gastrointestinal disorders Dyspepsia	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Asthenia	5.9% 1/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Induration	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Influenza like illness	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Injection site erythema	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Injection site inflammation	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Injection site pain	29.4% 5/17 • Number of events 7 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Injection site reaction	11.8% 2/17 • Number of events 6 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Oedema	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Oedema peripheral	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
General disorders Pyrexia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Immune system disorders Hypersensitivity	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Bacterial infection	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Bronchitis	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Folliculitis	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Nasopharyngitis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Rhinitis	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Infections and infestations Upper respiratory tract infection	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Injury, poisoning and procedural complications Rib fracture	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Injury, poisoning and procedural complications Wound	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Investigations Antinuclear antibody positive	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Investigations Blood creatine increased	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Metabolism and nutrition disorders Hypokalaemia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Metabolism and nutrition disorders Iron overload	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Number of events 2 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia recurrent	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Nervous system disorders Dysaesthesia	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Nervous system disorders Headache	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Nervous system disorders Syncope	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Psychiatric disorders Delirium	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Renal and urinary disorders Cystitis haemorrhagic	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Renal and urinary disorders Dysuria	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Erythema	17.6% 3/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Hyperhidrosis	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Pruritus	11.8% 2/17 • Number of events 3 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Purpura	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 5 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Rash papular	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Skin induration	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Skin and subcutaneous tissue disorders Skin ulcer	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Vascular disorders Flushing	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Vascular disorders Haematoma	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).
Vascular disorders Hypertension	5.9% 1/17 • Number of events 1 • Unsolicited AEs: starting with the first administration of study treatment (Week 1) and ending 30 days after the last study treatment administration (Month 49); SAEs: During the entire study (From Month 0 to Month 49). As per protocol, safety data was performed on and tabulated for the entire population (Total Treated Group).

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