Trial Outcomes & Findings for Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML) (NCT NCT00725283)

Last Updated: 2018-08-07

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: 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). * An allergic reaction/hypersensitivity 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

34 participants

Primary outcome timeframe

During the study treatment period (From Day 0 to Month 48)

Results posted on

2018-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2130579A Group Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Overall Study STARTED	34
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2130579A Group Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Overall Study Missing Code	3
Overall Study Death	5
Overall Study Other	6
Overall Study Withdrawal by Subject	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2130579A Group n=34 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Age, Continuous	60.1 Years STANDARD_DEVIATION 12.3 • n=34 Participants
Sex: Female, Male Female	18 Participants n=34 Participants
Sex: Female, Male Male	16 Participants n=34 Participants

PRIMARY outcome

Timeframe: During the study treatment period (From Day 0 to Month 48)

Population: This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=34 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Number of Patients With Severe Toxicities Encephalitis	1 Participants
Number of Patients With Severe Toxicities Rash erythematous	1 Participants
Number of Patients With Severe Toxicities Hypersensitivity	1 Participants
Number of Patients With Severe Toxicities Angina pectoris	1 Participants
Number of Patients With Severe Toxicities Rash	1 Participants
Number of Patients With Severe Toxicities Thrombocytopenia	1 Participants

PRIMARY outcome

Timeframe: At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]

Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=31 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 0	2 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 5	6 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 9	21 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 13	24 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 15	21 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 21	21 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 32	19 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 40	18 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Week 54	16 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 15	12 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 18	9 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 21	6 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 24	5 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 30	1 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 49	15 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 52	7 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 55	7 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 58	6 Participants
Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies Month 61	3 Participants

PRIMARY outcome

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=31 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Concentrations for Anti-WT1 Antibodies Week 0	4.8 EU/mL Interval 4.4 to 5.2
Concentrations for Anti-WT1 Antibodies Week 5	6.3 EU/mL Interval 4.8 to 8.3
Concentrations for Anti-WT1 Antibodies Week 9	145.3 EU/mL Interval 66.3 to 318.5
Concentrations for Anti-WT1 Antibodies Week 13	337.6 EU/mL Interval 185.2 to 615.4
Concentrations for Anti-WT1 Antibodies Week 15	313.4 EU/mL Interval 165.0 to 595.4
Concentrations for Anti-WT1 Antibodies Week 21	296.9 EU/mL Interval 162.2 to 543.5
Concentrations for Anti-WT1 Antibodies Week 32	285.3 EU/mL Interval 165.3 to 492.4
Concentrations for Anti-WT1 Antibodies Week 40	173.7 EU/mL Interval 100.7 to 299.8
Concentrations for Anti-WT1 Antibodies Week 54	174.9 EU/mL Interval 103.0 to 296.8
Concentrations for Anti-WT1 Antibodies Month 15	111.0 EU/mL Interval 53.5 to 230.0
Concentrations for Anti-WT1 Antibodies Month 18	111.3 EU/mL Interval 41.5 to 298.3
Concentrations for Anti-WT1 Antibodies Month 21	74.6 EU/mL Interval 22.3 to 249.5
Concentrations for Anti-WT1 Antibodies Month 24	76.7 EU/mL Interval 12.8 to 459.3
Concentrations for Anti-WT1 Antibodies Month 30	80.0 EU/mL The lower and upper limits (LL and UL) of the confidence interval (CI) could not be configured due to only 1 participant at Month 30.
Concentrations for Anti-WT1 Antibodies Month 49	45.3 EU/mL Interval 19.6 to 105.0
Concentrations for Anti-WT1 Antibodies Month 52	25.6 EU/mL Interval 9.6 to 68.5
Concentrations for Anti-WT1 Antibodies Month 55	18.7 EU/mL Interval 8.3 to 42.1
Concentrations for Anti-WT1 Antibodies Month 58	24.0 EU/mL Interval 11.9 to 48.6
Concentrations for Anti-WT1 Antibodies Month 61	25.5 EU/mL Interval 14.2 to 45.8

PRIMARY outcome

Timeframe: At Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]

Treatment response was defined as: For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=25 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Number of Patients With Anti-WT1 Antibody Response Month 61	3 Participants
Number of Patients With Anti-WT1 Antibody Response Week 13	22 Participants
Number of Patients With Anti-WT1 Antibody Response Week 5	4 Participants
Number of Patients With Anti-WT1 Antibody Response Week 9	20 Participants
Number of Patients With Anti-WT1 Antibody Response Week 15	19 Participants
Number of Patients With Anti-WT1 Antibody Response Week 21	19 Participants
Number of Patients With Anti-WT1 Antibody Response Week 32	17 Participants
Number of Patients With Anti-WT1 Antibody Response Week 40	16 Participants
Number of Patients With Anti-WT1 Antibody Response Week 54	14 Participants
Number of Patients With Anti-WT1 Antibody Response Month 15	10 Participants
Number of Patients With Anti-WT1 Antibody Response Month 18	7 Participants
Number of Patients With Anti-WT1 Antibody Response Month 21	4 Participants
Number of Patients With Anti-WT1 Antibody Response Month 24	3 Participants
Number of Patients With Anti-WT1 Antibody Response Month 30	1 Participants
Number of Patients With Anti-WT1 Antibody Response Month 49	15 Participants
Number of Patients With Anti-WT1 Antibody Response Month 52	7 Participants
Number of Patients With Anti-WT1 Antibody Response Month 55	7 Participants
Number of Patients With Anti-WT1 Antibody Response Month 58	6 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) post-administration period

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.

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=34 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Number of Patients With Any Unsolicited Adverse Events	33 Participants

SECONDARY outcome

Timeframe: During the whole study duration (From Day 0 up to the concluding visit, at Month 49)

Serious adverse events (SAEs) assessed include any medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. 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 Clinical Report Form (CRF), but not as an SAE.

Outcome measures

Outcome measures
Measure	GSK2130579A Group n=34 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Number of Patients With Any Serious Adverse Events (SAEs)	8 Participants

SECONDARY outcome

Timeframe: During the whole study duration (From Day 0 up to the concluding visit, at Month 49)

Serious adverse events (SAEs) assessed include medical occurrences related to treatment administration that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. 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	GSK2130579A Group n=34 Participants Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Number of Patients With Serious Adverse Events Related to Study Treatment	3 Participants

Adverse Events

GSK2130579A Group

Serious events: 8 serious events

Other events: 33 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	GSK2130579A Group n=34 participants at risk Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Blood and lymphatic system disorders Thrombocytopenia	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Cardiac disorders Myocardial infarction	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Abdominal pain	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Oesophagitis	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Small intestinal obstruction	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Immune system disorders Hypersensitivity	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Encephalitis	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Pneumonia	2.9% 1/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Upper respiratory tract infection	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Viral infection	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Wound infection	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Psychiatric disorders Anxiety	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.9% 1/34 • Number of events 1 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).

Other adverse events

Other adverse events
Measure	GSK2130579A Group n=34 participants at risk Patients with cytologically proven Acute Myeloid Leukemia (AML), as defined by the World Health Organization classification, who were administered a standard dose of GSK2130579A treatment. Patients received 24 doses of the study treatment over a period of approximately 4 years, administered in 4 cycles (Cycle 1: 6 doses, given at 2-week intervals; Cycle 2: 6 doses, given at 3-week intervals; Cycle 3: 4 doses, given at 6-week intervals; Cycle 4: 4 doses, given at 3-month intervals followed by other 4 doses, given at 6-month intervals).
Blood and lymphatic system disorders Anaemia	11.8% 4/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Blood and lymphatic system disorders Increased tendency to bruise	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Blood and lymphatic system disorders Leukopenia	17.6% 6/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Blood and lymphatic system disorders Lymphopenia	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Blood and lymphatic system disorders Neutropenia	17.6% 6/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Blood and lymphatic system disorders Thrombocytopenia	29.4% 10/34 • Number of events 17 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Abdominal pain	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Constipation	26.5% 9/34 • Number of events 10 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Diarrhoea	29.4% 10/34 • Number of events 15 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Dry mouth	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Nausea	26.5% 9/34 • Number of events 24 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Gastrointestinal disorders Vomiting	11.8% 4/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Asthenia	11.8% 4/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Chills	8.8% 3/34 • Number of events 4 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Cyst	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Fatigue	50.0% 17/34 • Number of events 40 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Influenza like illness	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Injection site erythema	14.7% 5/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Injection site pain	64.7% 22/34 • Number of events 78 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Injection site pruritus	11.8% 4/34 • Number of events 13 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Injection site reaction	17.6% 6/34 • Number of events 15 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Injection site swelling	8.8% 3/34 • Number of events 4 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Oedema peripheral	17.6% 6/34 • Number of events 11 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Pain	20.6% 7/34 • Number of events 9 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
General disorders Pyrexia	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Bronchitis	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Herpes zoster	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Upper respiratory tract infection	29.4% 10/34 • Number of events 15 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Infections and infestations Urinary tract infection	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Injury, poisoning and procedural complications Contusion	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Injury, poisoning and procedural complications Procedural pain	8.8% 3/34 • Number of events 4 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Injury, poisoning and procedural complications Skin abrasion	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Investigations Alanine aminotransferase increased	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Investigations Aspartate aminotransferase increased	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Metabolism and nutrition disorders Decreased appetite	11.8% 4/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Metabolism and nutrition disorders Hyperglycaemia	8.8% 3/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Metabolism and nutrition disorders Hyperkalaemia	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Metabolism and nutrition disorders Hypokalaemia	11.8% 4/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Metabolism and nutrition disorders Iron overload	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 6/34 • Number of events 10 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Back pain	23.5% 8/34 • Number of events 9 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Bone pain	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Muscle spasms	14.7% 5/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Muscular weakness	5.9% 2/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Myalgia	11.8% 4/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Neck pain	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Musculoskeletal and connective tissue disorders Pain in extremity	29.4% 10/34 • Number of events 19 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Dizziness	47.1% 16/34 • Number of events 25 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Headache	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Hypoaesthesia	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Neuropathy peripheral	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Post herpetic neuralgia	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Nervous system disorders Sciatica	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Psychiatric disorders Anxiety	11.8% 4/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Psychiatric disorders Insomnia	14.7% 5/34 • Number of events 6 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Renal and urinary disorders Haematuria	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Reproductive system and breast disorders Breast pain	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Cough	14.7% 5/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	17.6% 6/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 2/34 • Number of events 4 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Sinus congestion	14.7% 5/34 • Number of events 9 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	5.9% 2/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Dry skin	17.6% 6/34 • Number of events 7 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Erythema	14.7% 5/34 • Number of events 8 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Night sweats	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Onychoclasis	5.9% 2/34 • Number of events 4 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Pruritus	17.6% 6/34 • Number of events 9 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Rash	14.7% 5/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Rash erythematous	8.8% 3/34 • Number of events 5 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Skin and subcutaneous tissue disorders Skin lesion	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Vascular disorders Hypertension	8.8% 3/34 • Number of events 3 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).
Vascular disorders Hypotension	5.9% 2/34 • Number of events 2 • Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-administration period; Serious adverse events (SAEs): during the entire study period (from Month 0 up to Month 49).

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