Trial Outcomes & Findings for A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients (NCT NCT00849875)

Last Updated: 2017-07-12

Results Overview

The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product 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. Related = AE assessed by the investigator as related to the treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

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

Results posted on

2017-07-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	GSK2132231A GROUP Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
Overall Study STARTED	48
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2132231A GROUP Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
Overall Study Death	28
Overall Study Ongoing (unknown completion status)	11
Overall Study Others	6
Overall Study Lost to Follow-up	2

Baseline Characteristics

A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	Total n=48 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 15.4 • n=5 Participants	56.1 Years STANDARD_DEVIATION 18 • n=7 Participants	66 Years STANDARD_DEVIATION 0 • n=5 Participants	55.44 Years STANDARD_DEVIATION 15.99 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	27 Participants n=4 Participants

PRIMARY outcome

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

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Dyspepsia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site oedema, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Metabolism and nutrition disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Myalgia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Myalgia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any event, Grade 3	3 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any event, Grade 4	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Blood and lymphatic system disorders, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Blood and lymphatic system disorders, Grade 4	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Anaemia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Anaemia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Lymphopenia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Lymphopenia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Neutropenia, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Neutropenia, Grade 4	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Thrombocytopenia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Thrombocytopenia, Grade 4	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Cardiac disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Cardiac disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Tachycardia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Tachycardia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Gastrointestinal disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Gastrointestinal disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Constipation, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Constipation, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Diarrhoea, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Diarrhoea, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Dyspepsia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Nausea, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Nausea, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Paraesthesia oral, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Paraesthesia oral, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Vomiting, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Vomiting, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Gen. disord. and adm. site conditions, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Gen. disord. and adm. site conditions, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Asthenia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Asthenia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Chills, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Chills, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Fatigue, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Fatigue, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Influenza like illness, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Influenza like illness, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site erythema, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site erythema, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site inflammation, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site inflammation, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site oedema, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site pain, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site pain, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site reaction, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Injection site reaction, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Mucosal dryness, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Mucosal dryness, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Oedema peripheral, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Oedema peripheral, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pyrexia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pyrexia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Investigations, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Investigations, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Haemoglobin decreased, Grade 3	1 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Haemoglobin decreased, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Metabolism and nutrition disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Decreased appetite, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Decreased appetite, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Musculoskeletal and conn. Tiss. Diso., Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Musculoskeletal and conn. Tiss. Diso., Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Arthralgia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Arthralgia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pain in extremity, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pain in extremity, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Nervous system disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Nervous system disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Burning sensation, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Burning sensation, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Headache, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Headache, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Paraesthesia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Paraesthesia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Presyncope, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Presyncope, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Psychiatric disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Psychiatric disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Insomnia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Insomnia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Resp., thoracic and mediastinal. dis., Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Resp., thoracic and mediastinal. dis., Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Rhinitis allergic, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Rhinitis allergic, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Skin and subcutaneous tissue disorder, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Skin and subcutaneous tissue disorder, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Alopecia, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Alopecia, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Eczema, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Eczema, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Photosensitivity reaction, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Photosensitivity reaction, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pruritus, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Pruritus, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Vascular disorders, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Any Vascular disorders, Grade 4	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Hypotension, Grade 3	0 Patients	—	—	—
Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. Hypotension, Grade 4	0 Patients	—	—	—

PRIMARY outcome

Timeframe: During the entire study period, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients Reported With Serious Adverse Events (SAEs)	10 Patients	—	—	—

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=28 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=19 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=8 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3)	28 Patients	19 Patients	8 Patients	1 Patients

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Population: The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.

Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL)

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=28 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=19 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=8 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Anti-MAGE-A3 Antibody Concentrations	2778.7 EL.U/mL Interval 1638.3 to 4712.8	2650.8 EL.U/mL Interval 1425.5 to 4929.2	4046.9 EL.U/mL Interval 1206.5 to 13574.7	336.0 EL.U/mL As this analysis was performed on 1 patient, there were no statistics per se, hence no confidence intervals.

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=28 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=19 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=8 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies	28 Patients	19 Patients	8 Patients	1 Patients

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=28 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=19 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=8 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Concentrations of Antibodies Against Protein D (Anti-PD)	9979.6 EL.U/mL Interval 6470.0 to 15393.0	10437 EL.U/mL Interval 5932.8 to 18361.0	10853.6 EL.U/mL Interval 4823.4 to 24422.7	2176 EL.U/mL As the analysis was performed on 1 patient, there were no statistics per se and hence no confidence interval.

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 100 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=28 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=19 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=8 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Treatment Response for Anti-PD	28 Patients	19 Patients	8 Patients	1 Patients

PRIMARY outcome

Timeframe: Post Dose 4 at Week 13 (W13).

Analysis of MAGE-A3 cellular response was not performed and data were not collected..

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ \& 10 in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter \[LD\]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR = Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis; PR = At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment OR	4 patients	4 patients	0 patients	0 patients
Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment CR	1 patients	1 patients	0 patients	0 patients
Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment PR	3 patients	3 patients	0 patients	0 patients

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. TLs and NTLs were assessed as regards matching or not SD-related definitions, 1) SD definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria for TLs \>= 20 mm and TLs both \>= and \< 20 mm: a) for TLs: SD = Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since treatment start. and b) for NTLs: SD = Persistence of one or more NTL; 2) following below criteria for TLs \< 20mm e. a. a) for TLs: PR/SD = Neither sufficient shrinkage to qualify for CR nor sufficient increase, to qualify for PD taking as references the smallest sum LD since treatment start, and b) for NTLs: PR/SD = Persistence of one or more NTL.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment SD	5 patients	4 patients	0 patients	1 patients
Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment SD/PR	0 patients	0 patients	0 patients	0 patients

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. Stable disease was defined as follows: 1) In case of target lesions (TL) greater than or equal to (≥) 20 mm: neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as references the sum of Longest Diameter (LD) of TL recorded previously but not necessarily at baseline; 2) In case of TL both less than 20 mm and ≥ 20 mm: Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since the start of the treatment. The minimal time interval required between 2 measurements for determination of SD was at least 12 weeks.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=6 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=2 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=1 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Duration of Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment	5.6 Months Interval 5.3 to 8.3	7.7 Months Interval 7.2 to 8.3	5.1 Months The limits for the confidence interval were not available.	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. MLs were assessed as regards matching below MxR definitions. In case of evaluability per RECIST: a) MxR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL, and = SD/PR with new lesion. In case of non-evaluability per RECIST: a) MxR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL = SD/PR with new lesion.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Mixed Response (MxR) to MAGE-A3 ASCI Study Treatment MxR: SD/PR with new lesion	10 Patients	6 Patients	4 Patients	0 Patients
Number of Patients With Mixed Response (MxR) to MAGE-A3 ASCI Study Treatment MxR: SD/PD with target lesion regression	1 Patients Interval 0.0 to	0 Patients	1 Patients	0 Patients

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

TTF was defined as withdrawal from treatment with the MAGE-A3 ASCI study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=32 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=15 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=1 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Time to Treatment Failure (TTF), by Gene Signature	2.8 Months Interval 2.1 to 4.9	2.3 Months Interval 2.1 to 3.0	4.3 Months The limits for the confidence interval were not available.	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Progression-free Survival (PFS) for the Overall Population	2.8 Months Interval 2.8 to 3.0	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Progression-free Survival (PFS) by Gene Signature	2.8 Months Interval 2.8 to 3.0	2.8 Months Interval 2.8 to 3.4	2.8 Months Interval 2.2 to 3.3	5.1 Months The limits for the confidence interval were not available.

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

PFS after initial SPD was defined and calculated as the time from the time point at which the disease was the most advanced during the treatment to either a new progression of the disease or the date to death, whichever occurred first as another secondary outcome of this study. In that case, the largest diameter during the course of treatment was to be used as reference measurement. This outcome was defined to take into account the delay to induce an active immune response and the strict rules set up in this study to allow pursuing investigational treatment in case of SPD. PFS after SPD analysis was performed using the non-parametric Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=32 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=15 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=1 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Progression-free Survival (PFS) After Slow Progressive Disease (SPD) by Gene Signature	2.8 Months Interval 2.8 to 5.3	2.8 Months Interval 2.2 to 3.3	5.1 Months The limits for the confidence interval were not available.	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

OS was defined as the time from first treatment to the date of death. OS analysis was performed using the non-parametric Kaplan-Meier method. Each patient was censored out at the time of death.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group n=32 Participants Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group n=15 Participants Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group n=1 Participants Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Overall Survival (OS) by Gene Signature	9.4 Months Interval 5.8 to 15.8	11.4 Months Interval 7.3 to 17.1	5.3 Months Interval 3.3 to 10.5	0 Months The limits for the confidence interval were not available.

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.

The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE G0	34 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE G1	3 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G0; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE G0	3 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE G1	2 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G1; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE G0	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade ALT - SCR G2; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE G0	36 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE G1	2 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE G4	1 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G0; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE G1	3 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade AST - SCR G1; SE UNK	1 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE G0	31 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE G1	11 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G0; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE G1	3 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade ALK - SCR G1; SE UNK	1 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR UNK; SE UNK	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE G0	39 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE G1	3 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade. BIL - SCR G0; SE UNK	5 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE G0	40 Subjects	—	—	—
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE G1	4 Subjects	—	—	—
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE G4	1 Subjects	—	—	—
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade CREA - SCR G0; SE UNK	2 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards GGT laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE G0	20 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE G1	11 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE G2	4 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE G1	2 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G1; SE UNK	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE G0	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade GGT - SCR G3; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE G0	22 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE G1	14 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE G2	5 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE G1	2 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade HGB - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards HCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR UNK; SE UNK	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE G0	37 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G0; SE UNK	6 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G1; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G1; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade HCA - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards HKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE G0	42 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE G1	2 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G0; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G1; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade HKA - SCR G2; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards HNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE G0	44 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade HNA - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards hAL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR UNK; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE G0	26 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE G1	4 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE G2	2 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G0; SE UNK	4 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G1; SE G1	4 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G1; SE G2	3 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade hAL - SCR G1; SE UNK	2 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards hCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE G4	1 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR UNK; SE UNK	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE G0	27 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE G1	7 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G0; SE UNK	5 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE G0	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE G1	5 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade hCA - SCR G1; SE UNK	1 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards hKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE G0	42 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G0; SE UNK	1 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE G0	3 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade hKA - SCR G1; SE UNK	1 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards hNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE G0	33 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE G1	10 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade hNA - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE G0	37 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE G1	6 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE G0	0 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade LEU - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE G0	18 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE G1	13 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE G2	6 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE G0	2 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE G1	4 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE G2	3 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade LYM - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE G0	39 Subjects	—	—	—
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE G1	4 Subjects	—	—	—
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE G3	2 Subjects	—	—	—
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade NEU - SCR G0; SE UNK	2 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards PTT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE UNK	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE G0	35 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE G1	3 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE G3	1 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G0; SE UNK	7 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE G0	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE G1	1 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade PTT - SCR G1; SE G3	1 Subjects	—	—	—

SECONDARY outcome

Timeframe: During the entire study, up to 5 years

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE G0	39 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE G1	5 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE G2	1 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G0; SE UNK	2 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE G0	1 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE G1	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE G2	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE G3	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE G4	0 Subjects	—	—	—
Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade PLT - SCR G1; SE UNK	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: Within the 31-day follow-up period post treatment administration.

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with any AEs	48 Subjects	—	—	—
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with G1 AEs	14 Subjects	—	—	—
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with G2 AEs	19 Subjects	—	—	—
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with G3 AEs	12 Subjects	—	—	—
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with G4 AEs	3 Subjects	—	—	—
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Patients with G5 AEs	0 Subjects	—	—	—

SECONDARY outcome

Timeframe: Within the 31-day follow-up period post treatment administration.

Population: The Total Treated population included all patients who have received at least one dose of GSK2132231A.

SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.

Outcome measures

Outcome measures
Measure	GSK2132231A GROUP n=48 Participants Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.	GSK2132231A GS+ Group Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS- Group Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.	GSK2132231A GS Unknown Group Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with any SAEs	10 Subjects	—	—	—
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with G1 SAEs	1 Subjects	—	—	—
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with G2 SAEs	2 Subjects	—	—	—
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with G3 SAEs	5 Subjects	—	—	—
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with G4 SAEs	2 Subjects	—	—	—
Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade Patients with G5 SAEs	0 Subjects	—	—	—

Adverse Events

GSK2132231A GROUP

Serious events: 10 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2132231A GROUP n=48 participants at risk Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Cardiac disorders Palpitations	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Blood and lymphatic system disorders Neutropenia	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Blood and lymphatic system disorders Pancytopenia	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Blood and lymphatic system disorders Thrombocytopenia	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Asthenia	4.2% 2/48 • Number of events 2 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Chest pain	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Pyrexia	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Gastrointestinal disorders Intestinal obstruction	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Gastrointestinal disorders Vomiting	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Metabolism and nutrition disorders Decreased appetite	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Infections and infestations Device related infection	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Infections and infestations Gastroenteritis	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Infections and infestations Sepsis	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Infections and infestations Urinary tract infection	2.1% 1/48 • Number of events 1 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

Other adverse events

Other adverse events
Measure	GSK2132231A GROUP n=48 participants at risk Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
General disorders Asthenia	52.1% 25/48 • Number of events 25 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Injection site pain	37.5% 18/48 • Number of events 18 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Pyrexia	29.2% 14/48 • Number of events 14 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Injection site reaction	18.8% 9/48 • Number of events 9 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Influenza like illness	18.8% 9/48 • Number of events 9 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
General disorders Fatigue	18.8% 9/48 • Number of events 9 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Gastrointestinal disorders Nausea	45.8% 22/48 • Number of events 22 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Gastrointestinal disorders Constipation	29.2% 14/48 • Number of events 14 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Gastrointestinal disorders Vomiting	27.1% 13/48 • Number of events 13 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Metabolism and nutrition disorders Decreased appetite	22.9% 11/48 • Number of events 11 • SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

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